Dry Eye SyndromesPhase 1PRO-087/INCT03524157
Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects
A Phase 1 study testing PRO-087, Systane Ultra and Xyel Ofteno in people with Dry Eye Syndromes and Lubricant Allergy, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Lubricant Allergy, Tear Disorder
- What is being tested?
- PRO-087, Systane Ultra and Xyel Ofteno
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 17 Jul 2017to 27 Mar 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically and ophthalmologically healthy subjects
- Signed informed consent.
- Age between 18 to 40 years.
- Both genders
- Blood tests [complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)] within normal parameters
- Visual capacity 20/30 or better
Who cannot join
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Women who are pregnant or breastfeeding.
- Women without a history of hysterectomy, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
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- Diagnosis of liver disease or triple the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
- Inability to attend or answer the evaluations made in each of the visits.
- Positive smoking (specified as cigarette consumption regardless of quantity and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Users of contact lenses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Read the detailed description
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Study period:
3 to 4 months
treatment duration: 10 days
Number of patients:
30 subjects, divided into 3 groups,10 subjects (20 eyes) exposed by group.
Diagnosis and main inclusion criteria:
- Systemically and ophthalmologically healthy subjects
- Signed informed consent.
- Age between 18 to 40 years
- Both genders
- Blood tests complete, blood count (BHC), three element blood chemistry (QS) and liver function tests, within normal parameters
- Visual capacity 20/30 or better
Test product, dose and route of administration:
- PRO-087. Chondroitin sulfate 0.18% / 0.1% sodium hyaluronate, ophthalmic solution preservative free. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Reference product, dose and route of administration:
- Xyel Ofteno®. Xanthan gum 0.09% / Chondroitin sulfate 0.1% / preservative-free ophthalmic solution. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
- Systane Ultra®. Polyethylene glycol 400 0.4%, propylene glycol 0.3%. made by Alcon Laboratories, Inc.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Evaluation criteria:
Primary security outcome variables:
- Goblet cells density .
- Presence of adverse events.
- Intraocular pressure.
- Visual ability
- Laboratory tests
- Epithelial defects in cornea and conjunctiva.
- Ophthalmological signs: conjunctival hyperemia, chemosis.
Secondary outcome variables:
- Tear film rupture time
- Life signs: heart rate, respiratory frequency systemic blood pressure.
- Subsequent segment
Primary outcome variables of tolerability:
- Burning
- Foreign body sensation
- Itching
- Eye comfort index
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Kruskal-Wallis test for quantitative variables. The difference between the qualitative variables will be analyzed by means of chi square (Chi2). An alpha ≤ 0.05 will be considered significant.
- Conditions
- Dry Eye Syndromes, Lubricant Allergy, Tear Disorder
- Being tested
- PRO-087, Systane Ultra, Xyel Ofteno
- Keywords
- Humylub PF, artificial tears, Ophthalmic lubricant, Chondroitin sulfate, Sodium hyaluronate
- 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.
PRO-087Drug
Also called chondroitin sulfate + sodium hyaluronate, Humylub PF, humylub preservative-free ophthalmic solution, humylub preservative-free ophthalmic solution PF
The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
Systane UltraDrug
Also called Polyethylene glycol 400 0.4%, propyleneglycol 0.3%
The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
Xyel OftenoDrug
Also called Xanthan gum 0.9 mg, sodium chondroitin sulfate
The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
| Study group | Role | What they receive |
|---|---|---|
| PRO-087 | Experimental | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Receives: Drug: PRO-087 |
| Xyel Ofteno | Active comparator | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. Receives: Drug: Xyel Ofteno |
| Systane ultra | Active comparator | Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. Receives: Drug: Systane Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goblet Cell Density (GCD)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Secondary outcomes (9)
Presence of Adverse Events (AEs)
the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Measured: during the 13 days of evaluation, including the safety call (day 13).
Intraocular Pressure (IOP)
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Epithelial Defects (ED)
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Breakup Time (BUT)
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Conjunctival Hyperemia (CH)
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very mild / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Moderate and severe are considered pathological.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Chemosis
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Ocular Burning (OB)
ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Foreign Body Sensation (FBS)
Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:
Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Ocular Pruritus (P)
Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:
Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.
Measured: will be evaluated at the end of the treatment at the final visit (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start17 Jul 2017
- Primary completion12 Feb 2018
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza Durán, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524157
- Sponsor's protocol ID
- SOPH087-0616/I
- Acronym
- PRO-087/I
- Status last verified
- May 2019
- First submitted
- 25 Apr 2018
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
PubMed 34707360
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects
- ClinicalTrials.gov ID
- NCT03524157
- Acronym / sponsor ID
- PRO-087/I / SOPH087-0616/I
- Conditions
- Dry Eye Syndromes, Lubricant Allergy, Tear Disorder
- Keywords
- Humylub PF, artificial tears, Ophthalmic lubricant, Chondroitin sulfate, Sodium hyaluronate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Detailed description
Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.
Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Study period:
3 to 4 months
treatment duration: 10 days
Number of patients:
30 subjects, divided into 3 groups,10 subjects (20 eyes) exposed by group.
Diagnosis and main inclusion criteria:
- Systemically and ophthalmologically healthy subjects
- Signed informed consent.
- Age between 18 to 40 years
- Both genders
- Blood tests complete, blood count (BHC), three element blood chemistry (QS) and liver function tests, within normal parameters
- Visual capacity 20/30 or better
Test product, dose and route of administration:
- PRO-087. Chondroitin sulfate 0.18% / 0.1% sodium hyaluronate, ophthalmic solution preservative free. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Reference product, dose and route of administration:
- Xyel Ofteno®. Xanthan gum 0.09% / Chondroitin sulfate 0.1% / preservative-free ophthalmic solution. made by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico. Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
- Systane Ultra®. Polyethylene glycol 400 0.4%, propylene glycol 0.3%. made by Alcon Laboratories, Inc.
Dosage: 1 drop 4 times a day during the waking period, both eyes Route of administration: topical ophthalmic.
Evaluation criteria:
Primary security outcome variables:
- Goblet cells density .
- Presence of adverse events.
- Intraocular pressure.
- Visual ability
- Laboratory tests
- Epithelial defects in cornea and conjunctiva.
- Ophthalmological signs: conjunctival hyperemia, chemosis.
Secondary outcome variables:
- Tear film rupture time
- Life signs: heart rate, respiratory frequency systemic blood pressure.
- Subsequent segment
Primary outcome variables of tolerability:
- Burning
- Foreign body sensation
- Itching
- Eye comfort index
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Kruskal-Wallis test for quantitative variables. The difference between the qualitative variables will be analyzed by means of chi square (Chi2). An alpha ≤ 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
| Arm | Type | Receives |
|---|---|---|
| PRO-087 | Experimental | Drug: PRO-087Dosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: chondroitin sulfate 0.18%, sodium hyaluronate 0.1% ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. |
| Xyel Ofteno | Active comparator | Drug: Xyel OftenoDosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days, Active principles: Xanthan gum 0.9 mg, sodium chondroitin sulfate 1.0 ophthalmic solution made by Laboratorios Sophia, S.A. de C.V., transparent solution, free of visible particles in a sterile multi-dose bottle. |
| Systane ultra | Active comparator | Drug: Systane UltraDosage: 1 drop in both eyes, 4 times a day during the waking period per 10 days Active principles: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%, Ophthalmic solution, multi-dose dropper bottle, made by Alcon Laboratories, Inc. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically and ophthalmologically healthy subjects
- Signed informed consent.
- Age between 18 to 40 years.
- Both genders
- Blood tests [complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)] within normal parameters
Key exclusion criteria (11 listed)
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Women who are pregnant or breastfeeding.
- Women without a history of hysterectomy, oophorectomy or hysterectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.
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 |
|---|---|---|
| PRO-087Also: chondroitin sulfate + sodium hyaluronate, Humylub PF, humylub preservative-free ophthalmic solution, humylub preservative-free ophthalmic solution PFThe intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13. | Drug | PRO-087 |
| Systane UltraAlso: Polyethylene glycol 400 0.4%, propyleneglycol 0.3%The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13. | Drug | Systane ultra |
| Xyel OftenoAlso: Xanthan gum 0.9 mg, sodium chondroitin sulfateThe intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13. | Drug | Xyel Ofteno |
Primary outcome
Goblet Cell Density (GCD)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter
9 secondary outcomes
Presence of Adverse Events (AEs)
Time frame: during the 13 days of evaluation, including the safety call (day 13).
Intraocular Pressure (IOP)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Epithelial Defects (ED)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Breakup Time (BUT)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Conjunctival Hyperemia (CH)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Chemosis
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Ocular Burning (OB)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Foreign Body Sensation (FBS)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Ocular Pruritus (P)
Time frame: will be evaluated at the end of the treatment at the final visit (day 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34707360Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Leopoldo Baiza Durán, MD study director
Laboratorios Sophia S.A de C.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRO-087, Systane Ultra and Xyel Ofteno in people with Dry Eye Syndromes and Lubricant Allergy, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
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 6 inclusion and 11 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 19 Jul 2019. 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 Mexico. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Goblet Cell Density (GCD) (time frame: will be evaluated at the end of the treatment at the final visit (day 10)). 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 NCT03524157, which also lists 1 linked publication.
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 19 Jul 2019.