Phase 2
N=201
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT05370495 ↗Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 — -2.04; -1.65; -2.15; -1.54 tCFS score on a scale of 0 - 20
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SY-201 Ophthalmic Solution 2.0% (Drug); SY-201 Ophthalmic Solution 1.0% (Drug); SY-201 Ophthalmic Solution 0.5% (Drug); SY-201 Ophthalmic Solution Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seinda Pharmaceutical Guangzhou Corporation
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60 |
-2.04; -1.65; -2.15; -1.54 | — |
| PRIMARY Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60 |
-18.9; -16.9; -20.0; -14.7 | — |
| SECONDARY Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60 |
-0.33; -0.36; -0.44; -0.18 | — |
| SECONDARY Change From Baseline in Symptom Severity Score (Subscale) at Day 60 |
-19.8; -19.7; -19.4; -11.5 | — |
Summary
This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).
Eligibility Criteria
- Inclusion Criteria
- Provide written informed consent prior to any study-related procedures.
- Are 18 years of age or older.
- Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
- Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.
Exclusion Criteria
- Unanesthetized Schirmer test score in either eye 25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye.
- Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
Data sourced from ClinicalTrials.gov (NCT05370495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.