CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 201 enrolled
Drug / intervention
SY-201 Ophthalmic Solution 2.0% +3 moredrug
Likely dose
SY-201 Ophthalmic Solution 0.5%, 1.0%, or 2.0%AI-extracted
Key inclusion· 3
  • ✓Age 18 years or older
  • ✓Best Corrected Visual Acuity (BCVA) in each eye of +0.7 LogMAR or better (ETDRS)
  • ✓Unanesthetized Schirmer test score ≥2 mm/5 minutes in each eye at Visit 1
Key exclusion· 5
  • ✕Unanesthetized Schirmer test score <2 mm/5 minutes in either eye
  • ✕Concomitant treatment, prior ocular procedure/surgery, or alteration of systemic medication dose at study entry that could interfere with trial assessment
  • ✕Corneal erosive disease (confluent staining NEI grade 4, confluent filaments) or other extensive corneal damage
  • ✕History of glaucoma or intraocular pressure (IOP) >25 mmHg at Visit 1 or history of elevated IOP (>25 mmHg)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05370495
NCT05370495Phase 2Completed
CompareCT.gov

A Phase 2, Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Dose-Response, Parallel-Group Study of SY-201 Ophthalmic Solution Versus Vehicle Control in Subjects With Dry Eye Disease

Seinda Pharmaceutical Guangzhou Corporation·interventional·Posted May 11, 2022·Updated Nov 26, 2024

In Brief

A Phase 2 clinical trial evaluating SY-201 Ophthalmic Solution 2.0%, SY-201 Ophthalmic Solution 1.0%, and 2 other interventions for Dry Eye Disease. Completed, enrolled 201 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMay 11, 2022
Enrollment StartJul 25, 2022
Primary CompletionMar 24, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.1 years ago

Interventions

SY-201 Ophthalmic Solution 2.0%drug

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%drug

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%drug

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicledrug

SY-201 Ophthalmic Solution Vehicle