Dry EyePhase 3NCT04470479
Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome
A Phase 3 study testing Pilocarpine Hydrochloride in people with Dry Eye, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study was to access the possible beneficial effects of oral use of pilocarpine in relieving signs and symptoms of patients with Sjogren's syndrome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Pilocarpine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2005to 1 Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Sjögren's syndrome, both in primary and secondary forms, whose diagnoses were established according to the criteria defined by the - American-European Consensus for the diagnosis of Sjögren's syndrome.
- Patients with the secondary form of the syndrome, collagen disease considered controlled by a rheumatologist, before the start of the trial and stable until the end of the study.
- Systemic therapy instituted up to two months before the beginning of the protocol.
- Literate patients.
- Signature of the informed consent form
Who cannot join
- Eye or eyelid surface disease not attributed to Sjogren's syndrome.
- Temporary or permanent occlusion of tear points.
- Use of contact lenses.
- Use of systemic medication that is known to influence tear flow.
- Need to modify the systemic treatment of the underlying disease during the trial.
- Pregnancy or breastfeeding.
- Known hypersensitivity reaction to pilocarpine hydrochloride.
- Severe cardio-pulmonary disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade Santa casa de Misericórdia de São Paulo
São Paulo, 01221010
About this study
The purpose of this study was to access the possible beneficial effects of oral use of pilocarpine in relieving signs and symptoms of patients with Sjogren's syndrome
Read the detailed description
After being informed about the study, its potential risks and having signed the informed consent form, this placebo-controlled, crossover study involved patients with Sjögren's syndrome to use oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, and tear ferning test. Side effects observed during the treatment period were also assessed.
- Conditions
- Dry Eye
- Being tested
- Pilocarpine Hydrochloride, Placebo
- Keywords
- dry eye, Sjogren, pilocarpine hydrochloride
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine HydrochlorideDrug
Also called Salagen
Oral pilocarpine hydrochloride 5mg tablets were administered four times a day for 10 weeks to half the group of selected patients. The other half ingested placebo in the same way. At the end of this period and after two weeks of washing out the medications, the patients had to invert the treatments.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine Hydrochloride | Experimental | Patients with Sjögren's syndrome were allocated to receive oral pilocarpine 20mg per day, (5mg every 6 hours, for ten weeks. Receives: Drug: Pilocarpine Hydrochloride |
| placebo | Placebo comparator | Patients with Sjögren's syndrome were allocated to receive placebo administered in the same way (1 tablet every 6 hours), for ten weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Ocular Surface Disease Index questionnaire at week 10
The Ocular Surface Disease Index is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials. The answers to the questions generate an index ranging from 0 to 100, where 0 means no complaints related to dry eye and 100 indicates complaints with maximum intensity. (Change = week 10 score - baseline score)
Measured: Baseline and week 10
Change from baseline Ocular Surface Disease Index questionnaire at week 22
The Ocular Surface Disease is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials. The answers to the questions generate an index ranging from 0 to 100, where 0 means no complaints related to dry eye and 100 indicates complaints with maximum intensity. (Change = week 22 score - baseline score)
Measured: Baseline and week 22
Change from baseline in the NEI-VFQ-25 questionnaire at week 10
The VFQ-25 is a reliable and validated 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. The set of responses provided scores between 0 and 100, where 0 means the maximum negative impact of the disease on the quality of life of patients and 100 means no negative impact of the disease on quality of life. (Change = week 10 score - baseline score)
Measured: Baseline and week 10
Change from baseline in the NEI-VFQ-25 questionnaire at week 22
The VFQ-25 is a reliable and validated 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. The set of responses provided scores between 0 and 100, where 0 means the maximum negative impact of the disease on the quality of life of patients and 100 means no negative impact of the disease on quality of life. (Change = week 22 score - baseline score)
Measured: Baseline and week 22
Change from baseline in tear breakup time test at week 10
Tear breakup time is a clinical test used to assess evaporative disease of dry eye. To measure tear breakup time, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is viewed under a cobalt blue lighting. The time of appearance of the first tear film break point, recorded in seconds, indicates the tear film breakup time. Times greater than 10 seconds are considered normal. (Change = week 10 measure - baseline measure)
Measured: Baseline and week 10
Change from baseline in tear breakup time test at week 22
Tear breakup time is a clinical test used to assess evaporative disease of dry eye. To measure tear breakup time, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is viewed under a cobalt blue lighting. The time of appearance of the first tear film break point, recorded in seconds, indicates the tear film breakup time. Times greater than 10 seconds are considered normal. (Change = week 22 measure - baseline measure)
Measured: Baseline and week 22
Change from baseline in score with rose bengal staining at week 10
When instilled in the ocular surface, the rose bengal dye will stain dead cells and spaces not covered by the tear film, being a method used to evaluate the damage to the ocular surface caused by the dry eye. For quantification, the van bijesterveld scale was used, which gives a score from 0 to 9 points according to the intensity of the color distributed onto the ocular surface. The van bijesterveld scale is described as follows:
The surface of the eye should be separated into three regions: the nasal bulbar conjunctiva, the cornea and the medial bulbar conjunctiva. Each of these regions may receive a score ranging from 0 to 3 points (0 = not colored, 1 = colored with distant points, 2 = colored with close points and 3 = colored with confluent points). The scores are then added up, generating a global score ranging from 0 to 9 points. Score 0 means no impairment of the ocular surface and score 9 means maximum impairment of the ocular surface).
(Change = week 10 - baseline measure)
Measured: Baseline and week 10
Change from baseline in score with rose bengal staining at week 22
When instilled in the ocular surface, the rose bengal dye will stain dead cells and spaces not covered by the tear film, being a method used to evaluate the damage to the ocular surface caused by the dry eye. For quantification, the van bijesterveld scale was used, which gives a score from 0 to 9 points according to the intensity of the color distributed onto the ocular surface. The van bijesterveld scale is described as follows:
The surface of the eye should be separated into three regions: the nasal bulbar conjunctiva, the cornea and the medial bulbar conjunctiva. Each of these regions may receive a score ranging from 0 to 3 points (0 = not colored, 1 = colored with distant points, 2 = colored with close points and 3 = colored with confluent points). The scores are then added up, generating a global score ranging from 0 to 9 points. Score 0 means no impairment of the ocular surface and score 9 means maximum impairment of the ocular surface).
(Change = week 22 - baseline measure)
Measured: Baseline and week 22
Change from baseline in corneal keratitis score with fluorescein dye at week 10
After dripping fluorescein dye on the ocular surface, the cornea of the patients was analyzed with the patient accommodated in the slit lamp and under cobalt blue light. Fluorescein will stain spaces without cells, which represents spaces in distress caused by dry eyes. The score used ranges from 0 to 3 points (0 = not colored, 1 = blush with distant points, 2 = blush with close points and 3 = blush with confluent points). Score 0 means no corneal involvement (absence of keratitis) and score 3 means maximum involvement of the ocular surface) (Change = week 10 - baseline score)
Measured: Baseline and week 10
Change from baseline in corneal keratitis score with fluorescein dye at week 22
After dripping fluorescein dye on the ocular surface, the cornea of the patients was analyzed with the patient accommodated in the slit lamp and under cobalt blue light. Fluorescein will stain spaces without cells, which represents spaces in distress caused by dry eyes. The score used ranges from 0 to 3 points (0 = not colored, 1 = blush with distant points, 2 = blush with close points and 3 = blush with confluent points). Score 0 means no corneal involvement (absence of keratitis) and score 3 means maximum involvement of the ocular surface) (Change = week 22 - baseline score)
Measured: Baseline and week 22
Change from baseline in The Schirmer test at week 10
The Schirmer test measures, in millimeters, the production of the tear film for five minutes. A strip of standardized paper is placed on the lateral third of the lower eyelid of both eyes and after 5 minutes. The tear moistens the paper and the reading of the moistening is done. The test can vary from 0 to 35 millimeters, being considered normal (normal tear flow) values greater than 10 millimeters. Values below 10 millimeters indicate dry eye and the lower the value, the more dry the eye.
(Change = week 10 - baseline measure)
Measured: Baseline and week 10
Change from baseline in The Schirmer test at week 22
The Schirmer test measures, in millimeters, the production of the tear film for five minutes. A strip of standardized paper is placed on the lateral third of the lower eyelid of both eyes and after 5 minutes. The tear moistens the paper and the reading of the moistening is done. The test can vary from 0 to 35 millimeters, being considered normal (normal tear flow) values greater than 10 millimeters. Values below 10 millimeters indicate dry eye and the lower the value, the more dry the eye.
(Change = week 22 - baseline measure)
Measured: Baseline and week 22
Change from baseline in Tear ferning test (Rolando'score) at week 10
The tear ferning test is a laboratory test but it has the potential to be applied in the clinic setting to investigate the tear film in a simple way. Drying a small sample of tear fluid onto a clean, glass microscope slide produces a characteristic crystallisation pattern, described as a 'tear ferning". The scale proposed by Rolando was used, which classifies the findings into 4 types (type 1, 2, 3 and 4), according to the teardrop crystallization pattern. Patterns 1 and 2 are considered normal and patterns 3 and 4 are considered abnormal and indicate that the tear has an inadequate composition and quality (Change = week 10 - baseline score)
Measured: Baseline and week 10
Change from baseline in Tear ferning test (Rolando'score) at week 22
The tear ferning test is a laboratory test but it has the potential to be applied in the clinic setting to investigate the tear film in a simple way. Drying a small sample of tear fluid onto a clean, glass microscope slide produces a characteristic crystallisation pattern, described as a 'tear ferning". The scale proposed by Rolando was used, which classifies the findings into 4 types (type 1, 2, 3 and 4), according to the teardrop crystallization pattern. Patterns 1 and 2 are considered normal and patterns 3 and 4 are considered abnormal and indicate that the tear has an inadequate composition and quality (Change = week 22 - baseline score)
Measured: Baseline and week 22
Secondary outcomes (2)
The frequency of systemic side effects most frequently reported by patients at week 10
A list of the systemic side effects most frequently described with the oral use of pilocarpine was presented to patients, where they could indicate the presence or absence of this effect: the side effects on the list are: sweating, chills, nausea, salivation, abdominal pain, dizziness, facial flushing, rhinitis, weakness, visual blurring, tremor, tachycardia, headache and diarrhea.
Measured: week 10
The frequency of systemic side effects most frequently reported by patients at week 22
A list of the systemic side effects most frequently described with the oral use of pilocarpine was presented to patients, where they could indicate the presence or absence of this effect: the side effects on the list are: sweating, chills, nausea, salivation, abdominal pain, dizziness, facial flushing, rhinitis, weakness, visual blurring, tremor, tachycardia, headache and diarrhea.
Measured: week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Mar 2005
- Primary completion1 Apr 2006
- Study completion1 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This was a placebo-controlled, crossover study that involved patients with Sjögren's syndrome to use 20mg/day of oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, tear ferning test, osmolarity and the activity of lysozyme. R
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Felberg, Federal University of São Paulo
- Investigators
- Sergio Felberg, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470479
- Sponsor's protocol ID
- 0910/03
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Detailed description of the methods may be made available after publication
Publications
Kawakita T, Shimmura S, Tsubota K. Effect of Oral Pilocarpine in Treating Severe Dry Eye in Patients With Sjogren Syndrome. Asia Pac J Ophthalmol (Phila). 2015 Mar-Apr;4(2):101-5. doi: 10.1097/APO.0000000000000040.
PubMed 26065354Cifuentes M, Del Barrio-Diaz P, Vera-Kellet C. Pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in Sjogren syndrome: a double-blind randomized controlled trial. Br J Dermatol. 2018 Nov;179(5):1056-1061. doi: 10.1111/bjd.16442. Epub 2018 May 29.
PubMed 29432648Papas AS, Sherrer YS, Charney M, Golden HE, Medsger TA Jr, Walsh BT, Trivedi M, Goldlust B, Gallagher SC. Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjogren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. doi: 10.1097/01.rhu.0000135553.08057.21.
PubMed 17043506
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome
- ClinicalTrials.gov ID
- NCT04470479
- Acronym / sponsor ID
- 0910/03
- Conditions
- Dry Eye
- Keywords
- dry eye, Sjogren, pilocarpine hydrochloride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Mar 2005 (actual)
- Primary completion
- 1 Apr 2006 (actual)
- Study completion
- 1 Apr 2006 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to access the possible beneficial effects of oral use of pilocarpine in relieving signs and symptoms of patients with Sjogren's syndrome
Detailed description
After being informed about the study, its potential risks and having signed the informed consent form, this placebo-controlled, crossover study involved patients with Sjögren's syndrome to use oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, and tear ferning test. Side effects observed during the treatment period were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a placebo-controlled, crossover study that involved patients with Sjögren's syndrome to use 20mg/day of oral pilocarpine or placebo for ten weeks and after two weeks of medication withdrawal, to invert the treatment for the same period of time. The assessments applied were the Ocular Surface Disease Index, NEI-VFQ-25 questionnaire, non-invasive break-up time, traditional break-up time, evaluation of the cornea and ocular surface with fluorescein and rose bengal dyes, Schirmer test, tear ferning test, osmolarity and the activity of lysozyme. R
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine Hydrochloride | Experimental | Drug: Pilocarpine HydrochloridePatients with Sjögren's syndrome were allocated to receive oral pilocarpine 20mg per day, (5mg every 6 hours, for ten weeks. |
| placebo | Placebo comparator | Drug: PlaceboPatients with Sjögren's syndrome were allocated to receive placebo administered in the same way (1 tablet every 6 hours), for ten weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Sjögren's syndrome, both in primary and secondary forms, whose diagnoses were established according to the criteria defined by the - American-European Consensus for the diagnosis of Sjögren's syndrome.
- Patients with the secondary form of the syndrome, collagen disease considered controlled by a rheumatologist, before the start of the trial and stable until the end of the study.
- Systemic therapy instituted up to two months before the beginning of the protocol.
- Literate patients.
- Signature of the informed consent form
Key exclusion criteria (8 listed)
- Eye or eyelid surface disease not attributed to Sjogren's syndrome.
- Temporary or permanent occlusion of tear points.
- Use of contact lenses.
- Use of systemic medication that is known to influence tear flow.
- Need to modify the systemic treatment of the underlying disease during the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilocarpine HydrochlorideAlso: SalagenOral pilocarpine hydrochloride 5mg tablets were administered four times a day for 10 weeks to half the group of selected patients. The other half ingested placebo in the same way. At the end of this period and after two weeks of washing out the medications, the patients had to invert the treatments. | Drug | Pilocarpine Hydrochloride |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Change from baseline in the Ocular Surface Disease Index questionnaire at week 10
Time frame: Baseline and week 10
The Ocular Surface Disease Index is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials. The answers to the questions generate an index ranging from 0 to 100, where 0 means no complaints related to dry eye and 100 indicates complaints with maximum intensity. (Change = week 10 score - baseline score)
Change from baseline Ocular Surface Disease Index questionnaire at week 22
Time frame: Baseline and week 22
The Ocular Surface Disease is a valid and reliable instrument for measuring the severity of dry eye disease, and it possesses the necessary psychometric properties to be used as an end point in clinical trials. The answers to the questions generate an index ranging from 0 to 100, where 0 means no complaints related to dry eye and 100 indicates complaints with maximum intensity. (Change = week 22 score - baseline score)
Change from baseline in the NEI-VFQ-25 questionnaire at week 10
Time frame: Baseline and week 10
The VFQ-25 is a reliable and validated 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. The set of responses provided scores between 0 and 100, where 0 means the maximum negative impact of the disease on the quality of life of patients and 100 means no negative impact of the disease on quality of life. (Change = week 10 score - baseline score)
Change from baseline in the NEI-VFQ-25 questionnaire at week 22
Time frame: Baseline and week 22
The VFQ-25 is a reliable and validated 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration. The set of responses provided scores between 0 and 100, where 0 means the maximum negative impact of the disease on the quality of life of patients and 100 means no negative impact of the disease on quality of life. (Change = week 22 score - baseline score)
Change from baseline in tear breakup time test at week 10
Time frame: Baseline and week 10
Tear breakup time is a clinical test used to assess evaporative disease of dry eye. To measure tear breakup time, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is viewed under a cobalt blue lighting. The time of appearance of the first tear film break point, recorded in seconds, indicates the tear film breakup time. Times greater than 10 seconds are considered normal. (Change = week 10 measure - baseline measure)
Change from baseline in tear breakup time test at week 22
Time frame: Baseline and week 22
Tear breakup time is a clinical test used to assess evaporative disease of dry eye. To measure tear breakup time, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is viewed under a cobalt blue lighting. The time of appearance of the first tear film break point, recorded in seconds, indicates the tear film breakup time. Times greater than 10 seconds are considered normal. (Change = week 22 measure - baseline measure)
Change from baseline in score with rose bengal staining at week 10
Time frame: Baseline and week 10
When instilled in the ocular surface, the rose bengal dye will stain dead cells and spaces not covered by the tear film, being a method used to evaluate the damage to the ocular surface caused by the dry eye. For quantification, the van bijesterveld scale was used, which gives a score from 0 to 9 points according to the intensity of the color distributed onto the ocular surface. The van bijesterveld scale is described as follows: The surface of the eye should be separated into three regions: the nasal bulbar conjunctiva, the cornea and the medial bulbar conjunctiva. Each of these regions may receive a score ranging from 0 to 3 points (0 = not colored, 1 = colored with distant points, 2 = colored with close points and 3 = colored with confluent points). The scores are then added up, generating a global score ranging from 0 to 9 points. Score 0 means no impairment of the ocular surface and score 9 means maximum impairment of the ocular surface). (Change = week 10 - baseline measure)
Change from baseline in score with rose bengal staining at week 22
Time frame: Baseline and week 22
When instilled in the ocular surface, the rose bengal dye will stain dead cells and spaces not covered by the tear film, being a method used to evaluate the damage to the ocular surface caused by the dry eye. For quantification, the van bijesterveld scale was used, which gives a score from 0 to 9 points according to the intensity of the color distributed onto the ocular surface. The van bijesterveld scale is described as follows: The surface of the eye should be separated into three regions: the nasal bulbar conjunctiva, the cornea and the medial bulbar conjunctiva. Each of these regions may receive a score ranging from 0 to 3 points (0 = not colored, 1 = colored with distant points, 2 = colored with close points and 3 = colored with confluent points). The scores are then added up, generating a global score ranging from 0 to 9 points. Score 0 means no impairment of the ocular surface and score 9 means maximum impairment of the ocular surface). (Change = week 22 - baseline measure)
Change from baseline in corneal keratitis score with fluorescein dye at week 10
Time frame: Baseline and week 10
After dripping fluorescein dye on the ocular surface, the cornea of the patients was analyzed with the patient accommodated in the slit lamp and under cobalt blue light. Fluorescein will stain spaces without cells, which represents spaces in distress caused by dry eyes. The score used ranges from 0 to 3 points (0 = not colored, 1 = blush with distant points, 2 = blush with close points and 3 = blush with confluent points). Score 0 means no corneal involvement (absence of keratitis) and score 3 means maximum involvement of the ocular surface) (Change = week 10 - baseline score)
Change from baseline in corneal keratitis score with fluorescein dye at week 22
Time frame: Baseline and week 22
After dripping fluorescein dye on the ocular surface, the cornea of the patients was analyzed with the patient accommodated in the slit lamp and under cobalt blue light. Fluorescein will stain spaces without cells, which represents spaces in distress caused by dry eyes. The score used ranges from 0 to 3 points (0 = not colored, 1 = blush with distant points, 2 = blush with close points and 3 = blush with confluent points). Score 0 means no corneal involvement (absence of keratitis) and score 3 means maximum involvement of the ocular surface) (Change = week 22 - baseline score)
Change from baseline in The Schirmer test at week 10
Time frame: Baseline and week 10
The Schirmer test measures, in millimeters, the production of the tear film for five minutes. A strip of standardized paper is placed on the lateral third of the lower eyelid of both eyes and after 5 minutes. The tear moistens the paper and the reading of the moistening is done. The test can vary from 0 to 35 millimeters, being considered normal (normal tear flow) values greater than 10 millimeters. Values below 10 millimeters indicate dry eye and the lower the value, the more dry the eye. (Change = week 10 - baseline measure)
Change from baseline in The Schirmer test at week 22
Time frame: Baseline and week 22
The Schirmer test measures, in millimeters, the production of the tear film for five minutes. A strip of standardized paper is placed on the lateral third of the lower eyelid of both eyes and after 5 minutes. The tear moistens the paper and the reading of the moistening is done. The test can vary from 0 to 35 millimeters, being considered normal (normal tear flow) values greater than 10 millimeters. Values below 10 millimeters indicate dry eye and the lower the value, the more dry the eye. (Change = week 22 - baseline measure)
Change from baseline in Tear ferning test (Rolando'score) at week 10
Time frame: Baseline and week 10
The tear ferning test is a laboratory test but it has the potential to be applied in the clinic setting to investigate the tear film in a simple way. Drying a small sample of tear fluid onto a clean, glass microscope slide produces a characteristic crystallisation pattern, described as a 'tear ferning". The scale proposed by Rolando was used, which classifies the findings into 4 types (type 1, 2, 3 and 4), according to the teardrop crystallization pattern. Patterns 1 and 2 are considered normal and patterns 3 and 4 are considered abnormal and indicate that the tear has an inadequate composition and quality (Change = week 10 - baseline score)
Change from baseline in Tear ferning test (Rolando'score) at week 22
Time frame: Baseline and week 22
The tear ferning test is a laboratory test but it has the potential to be applied in the clinic setting to investigate the tear film in a simple way. Drying a small sample of tear fluid onto a clean, glass microscope slide produces a characteristic crystallisation pattern, described as a 'tear ferning". The scale proposed by Rolando was used, which classifies the findings into 4 types (type 1, 2, 3 and 4), according to the teardrop crystallization pattern. Patterns 1 and 2 are considered normal and patterns 3 and 4 are considered abnormal and indicate that the tear has an inadequate composition and quality (Change = week 22 - baseline score)
2 secondary outcomes
The frequency of systemic side effects most frequently reported by patients at week 10
Time frame: week 10
The frequency of systemic side effects most frequently reported by patients at week 22
Time frame: week 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Results publication: PubMed 26065354Kawakita T, Shimmura S, Tsubota K. Effect of Oral Pilocarpine in Treating Severe Dry Eye in Patients With Sjogren Syndrome. Asia Pac J Ophthalmol (Phila). 2015 Mar-Apr;4(2):101-5. doi: 10.1097/APO.0000000000000040.
- Results publication: PubMed 29432648Cifuentes M, Del Barrio-Diaz P, Vera-Kellet C. Pilocarpine and artificial saliva for the treatment of xerostomia and xerophthalmia in Sjogren syndrome: a double-blind randomized controlled trial. Br J Dermatol. 2018 Nov;179(5):1056-1061. doi: 10.1111/bjd.16442. Epub 2018 May 29.
- Results publication: PubMed 17043506Papas AS, Sherrer YS, Charney M, Golden HE, Medsger TA Jr, Walsh BT, Trivedi M, Goldlust B, Gallagher SC. Successful Treatment of Dry Mouth and Dry Eye Symptoms in Sjogren's Syndrome Patients With Oral Pilocarpine: A Randomized, Placebo-Controlled, Dose-Adjustment Study. J Clin Rheumatol. 2004 Aug;10(4):169-77. doi: 10.1097/01.rhu.0000135553.08057.21.
- Individual participant dataSharing planned: Yes. Detailed description of the methods may be made available after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Felberg, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilocarpine Hydrochloride in people with Dry Eye, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Ocular Surface Disease Index questionnaire at week 10 (time frame: Baseline and week 10). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470479, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.