Status:
COMPLETED
Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Lead Sponsor:
Seinda Pharmaceutical Guangzhou Corporation
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief 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 Ophth...
Eligibility Criteria
Inclusion
- 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 \<2 mm/5 minutes at Visit 1.
- Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
- Have corneal erosive disease (e.g., confluent staining \[National Eye Institute (NEI) grade 4\], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
- Have a history of glaucoma or intraocular pressure (IOP) \>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.
Exclusion
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT05370495
Start Date
July 25 2022
End Date
March 24 2023
Last Update
November 26 2024
Active Locations (1)
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1
Lexitas
Durham, North Carolina, United States, 27703