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NCT05370495 | Completed | Dry Eye Disease

Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
Sponsor:

Seinda Pharmaceutical Guangzhou Corporation

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 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).

Condition or disease

Dry Eye Disease

Intervention/treatment

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

Phase

Phase 1

Phase 2

Study Type : Interventional
Estimated Enrollment : 201 participants
Masking : Quadruple
Masking Description : Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : July 25, 2022
Estimated Primary Completion Date : March 24, 2023
Estimated Study Completion Date : March 24, 2023
Arm Intervention/treatment

Experimental: SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 2.0%

Drug: SY-201 Ophthalmic Solution 2.0%

Experimental: SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 1.0%

Drug: SY-201 Ophthalmic Solution 1.0%

Experimental: SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution 0.5%

Drug: SY-201 Ophthalmic Solution 0.5%

Placebo Comparator: SY-201 Ophthalmic Solution Vehicle

SY-201 Ophthalmic Solution Vehicle

Drug: SY-201 Ophthalmic Solution Vehicle
Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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 [NEI grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
    • Have a history of glaucoma or 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.
    Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

    Location Details

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    Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    United States, North Carolina

    Literacy

    Durham, North Carolina, United States, 27703