Sjögren's SyndromeNCT03060005
Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
A study testing Tears Naturale Forte and liposic in people with Sjögren's Syndrome and Meibomian Gland Dysfunction, run by Tung Wah Hospital at 1 site in China.
Trial summary
The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and… Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sjögren's Syndrome, Meibomian Gland Dysfunction
- What is being tested?
- Tears Naturale Forte and liposic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Sep 2017
- Phase
- Interventional
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the subjects are female and age between 50-60 years
- Patients with primary SS fulfilled the criteria established by the European Study Group
- Patients with SLE and RA met the criteria set by the American College of Rheumatology
Who cannot join
- The control history of autoimmune disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tungwah Hospital of Sun Yat-sen University
Dongguan, Guangdong, 523000
Chi Zhang, MD,PhD, +8613790077756, mike0946@163.com
About this study
The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.
- Conditions
- Sjögren's Syndrome, Meibomian Gland Dysfunction
- Being tested
- Tears Naturale Forte, liposic
- Keywords
- Sjögren's syndrome, meibomian gland dysfunction, dry eye disease
- Medical subject headings
- Sjogren's Syndrome, Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tears Naturale ForteDrug
Also called DEXTRAN/HYPROMELLOSE/GLYCERIN
This medication is used to relieve dry, irritated eyes
liposicDrug
Also called Carbomer
Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatment of the symptoms of dry eye.
| Study group | Role | What they receive |
|---|---|---|
| primary Sjögren's syndrome | Experimental | The female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic. Receives: Drug: Tears Naturale Forte; Drug: liposic |
| secondary Sjögren's syndrome | Experimental | The female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic. Receives: Drug: Tears Naturale Forte; Drug: liposic |
| meibomian gland dysfunction | Experimental | The female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic. Receives: Drug: Tears Naturale Forte; Drug: liposic |
| control | Experimental | the female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic. Receives: Drug: Tears Naturale Forte; Drug: liposic |
What is being measured
The primary outcome is the main question the study is designed to answer.
meibomian gland function
assessment of the quality of meibomian gland secretions, according to a published classification system (21). In brief, the grading scheme was "0" for clear excreta with small particles, "1" for opaque excreta with normal viscosity, "2" for opaque excreta with increased viscosity, and "3" for secreta that retained shape after digital expression
Measured: up to 3 months after tear substitutes apply
Ocular Surface Disease Index
The OSDI questionnaire is used to quantify the dry eye symptoms. Subjects will be asked questions regarding the dry eye symptoms that they had experienced; the OSDI questions is drawn from 3 different subscales: ocular symptoms, vision-related functions, and environmental triggers. Each answer is scored on a 4-point scale from zero (indicating no problems) to four (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores indicating more severe symptoms. Symptoms of dry eye, such as dryness, burning, foreign body sensation, stabbing pain, photophobia, and visual fluctuations, are also noted
Measured: up to 3 months after tear substitutes apply
noninvasive tear breakup time
Four IR diodes were set on the Keratograph 5 (Oculus, Wetzlar, Germany) and arranged in two pairs, located one above the other. The red ring illumination used for corneal topography was deactivated; this ensured a dark background for the examination. An illuminated ring pattern was then projected onto the cornea. At the start of the recording, the subject will be asked to blink his or her eyes three times and then to keep them open as long as possible. Irregularities in the reflected image will be observed closely. Special attention will be given to distortions and gaps in individual rings and the time such deviations from the original ring pattern took to occur. The examination will be recorded on video.
Measured: up to 3 months after tear substitutes apply
fluorescein staining of the cornea
Upper, lower, nasal, temporal and central quadrants were used. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each quadrant: 0, no staining in the cornea; 1, <5 punctuate stains; 2, >5 punctuate stains but <10; and 3, >10 or filamentous staining detected. The total number was obtained by adding the scores of the four quadrants for each eye (0-15).
Measured: up to 3 months after tear substitutes apply
Schirmer's test with and without anesthesia
The Schirmer test without anesthesia (S1T) for tear secretion function will be performed by inserting a 30-mm Schirmer tear test strip (Jingming, Tianjing, China) into the inferior fornix at the junction of the middle and lateral thirds of the lower eyelid margin. Schirmer test strips will remain in place for 5 minutes with the eyes closed. The extent of wetting will be subsequently measured according to the scale provided by the manufacturer. Potential scores ranged from 0 to 30 mm, with lower scores indicating greater tear production abnormalities.
Measured: up to 3 months after tear substitutes apply
tear meniscus
The subject will be asked to blink her eyes once ,then the image of tear meniscus height will be captured by a Keratograph 5 (Oculus, Wetzlar, Germany).After that tear meniscus height will be measured at the centre of the lower lid margin. This performance will be taken three times and the average value will be recorded.
Measured: up to 3 months after tear substitutes apply
Secondary outcomes (1)
rose bengal staining of the conjunctiva
) rose bengal staining (graded on a 0-3 scale) of the conjunctiva (six nasal and temporal areas) and the whole cornea
Measured: up to 3 months after tear substitutes apply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 May 2017
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tung Wah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaolin Du, MD,PhD, Principal investigator, Tungwah Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060005
- Sponsor's protocol ID
- 2017DHLL001
- Status last verified
- May 2017
- First submitted
- 23 Jan 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
- ClinicalTrials.gov ID
- NCT03060005
- Acronym / sponsor ID
- 2017DHLL001
- Conditions
- Sjögren's Syndrome, Meibomian Gland Dysfunction
- Keywords
- Sjögren's syndrome, meibomian gland dysfunction, dry eye disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tung Wah HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Sep 2017 (estimated)
- First posted
- 23 Feb 2017 (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 investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| primary Sjögren's syndrome | Experimental | Drug: Tears Naturale Forte, Drug: liposicThe female patients with primary Sjögren's syndrome receive the Tears Naturale Forte and Liposic. |
| secondary Sjögren's syndrome | Experimental | Drug: Tears Naturale Forte, Drug: liposicThe female patients with secondary Sjögren's syndrome receive Tears Naturale Forte and Liposic. |
| meibomian gland dysfunction | Experimental | Drug: Tears Naturale Forte, Drug: liposicThe female patients with meibomian gland dysfunction receive the Tears Naturale Forte and Liposic. |
| control | Experimental | Drug: Tears Naturale Forte, Drug: liposicthe female had no history of autoimmune disease receive the Tears Naturale Forte and Liposic. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All the subjects are female and age between 50-60 years
- Patients with primary SS fulfilled the criteria established by the European Study Group
- Patients with SLE and RA met the criteria set by the American College of Rheumatology
Key exclusion criteria (1 listed)
- The control history of autoimmune disease
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 |
|---|---|---|
| Tears Naturale ForteAlso: DEXTRAN/HYPROMELLOSE/GLYCERINThis medication is used to relieve dry, irritated eyes | Drug | control, meibomian gland dysfunction, primary Sjögren's syndrome, secondary Sjögren's syndrome |
| liposicAlso: CarbomerLiposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatment of the symptoms of dry eye. | Drug | control, meibomian gland dysfunction, primary Sjögren's syndrome, secondary Sjögren's syndrome |
Primary outcome
meibomian gland function
Time frame: up to 3 months after tear substitutes apply
assessment of the quality of meibomian gland secretions, according to a published classification system (21). In brief, the grading scheme was "0" for clear excreta with small particles, "1" for opaque excreta with normal viscosity, "2" for opaque excreta with increased viscosity, and "3" for secreta that retained shape after digital expression
Ocular Surface Disease Index
Time frame: up to 3 months after tear substitutes apply
The OSDI questionnaire is used to quantify the dry eye symptoms. Subjects will be asked questions regarding the dry eye symptoms that they had experienced; the OSDI questions is drawn from 3 different subscales: ocular symptoms, vision-related functions, and environmental triggers. Each answer is scored on a 4-point scale from zero (indicating no problems) to four (indicating a significant problem). Responses to all of the questions are combined to generate a composite OSDI score that ranges from 0 to 100, with higher OSDI scores indicating more severe symptoms. Symptoms of dry eye, such as dryness, burning, foreign body sensation, stabbing pain, photophobia, and visual fluctuations, are also noted
noninvasive tear breakup time
Time frame: up to 3 months after tear substitutes apply
Four IR diodes were set on the Keratograph 5 (Oculus, Wetzlar, Germany) and arranged in two pairs, located one above the other. The red ring illumination used for corneal topography was deactivated; this ensured a dark background for the examination. An illuminated ring pattern was then projected onto the cornea. At the start of the recording, the subject will be asked to blink his or her eyes three times and then to keep them open as long as possible. Irregularities in the reflected image will be observed closely. Special attention will be given to distortions and gaps in individual rings and the time such deviations from the original ring pattern took to occur. The examination will be recorded on video.
fluorescein staining of the cornea
Time frame: up to 3 months after tear substitutes apply
Upper, lower, nasal, temporal and central quadrants were used. Superficial punctate keratopathy (SPK) in the cornea was scored from 0 to 3 in each quadrant: 0, no staining in the cornea; 1, <5 punctuate stains; 2, >5 punctuate stains but <10; and 3, >10 or filamentous staining detected. The total number was obtained by adding the scores of the four quadrants for each eye (0-15).
Schirmer's test with and without anesthesia
Time frame: up to 3 months after tear substitutes apply
The Schirmer test without anesthesia (S1T) for tear secretion function will be performed by inserting a 30-mm Schirmer tear test strip (Jingming, Tianjing, China) into the inferior fornix at the junction of the middle and lateral thirds of the lower eyelid margin. Schirmer test strips will remain in place for 5 minutes with the eyes closed. The extent of wetting will be subsequently measured according to the scale provided by the manufacturer. Potential scores ranged from 0 to 30 mm, with lower scores indicating greater tear production abnormalities.
tear meniscus
Time frame: up to 3 months after tear substitutes apply
The subject will be asked to blink her eyes once ,then the image of tear meniscus height will be captured by a Keratograph 5 (Oculus, Wetzlar, Germany).After that tear meniscus height will be measured at the centre of the lower lid margin. This performance will be taken three times and the average value will be recorded.
1 secondary outcome
rose bengal staining of the conjunctiva
Time frame: up to 3 months after tear substitutes apply
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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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.
Shaolin Du, MD,PhD principal investigator
Tungwah Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tears Naturale Forte and liposic in people with Sjögren's Syndrome and Meibomian Gland Dysfunction, run by Tung Wah Hospital at 1 site in China.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 May 2017. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi Zhang, MD,PhD (+8613790077756, mike0946@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meibomian gland function (time frame: up to 3 months after tear substitutes apply). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2017.