SY-201 Ophthalmic Solution 2.0% for Dry Eye Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lexitas, Durham, NC
Dry Eye Syndromes+3 More
SY-201 Ophthalmic Solution 2.0% - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 60 days

60 days
Adverse event
Eye dryness score
Total corneal fluorescein staining

Trial Safety

Trial Design

4 Treatment Groups

SY-201 Ophthalmic Solution 2.0%
1 of 4
SY-201 Ophthalmic Solution 1.0%
1 of 4
SY-201 Ophthalmic Solution 0.5%
1 of 4
SY-201 Ophthalmic Solution Vehicle
1 of 4
Experimental Treatment
Non-Treatment Group

200 Total Participants · 4 Treatment Groups

Primary Treatment: SY-201 Ophthalmic Solution 2.0% · Has Placebo Group · Phase 1 & 2

SY-201 Ophthalmic Solution 2.0%
Drug
Experimental Group · 1 Intervention: SY-201 Ophthalmic Solution 2.0% · Intervention Types: Drug
SY-201 Ophthalmic Solution 1.0%
Drug
Experimental Group · 1 Intervention: SY-201 Ophthalmic Solution 1.0% · Intervention Types: Drug
SY-201 Ophthalmic Solution 0.5%
Drug
Experimental Group · 1 Intervention: SY-201 Ophthalmic Solution 0.5% · Intervention Types: Drug
SY-201 Ophthalmic Solution Vehicle
Drug
PlaceboComparator Group · 1 Intervention: SY-201 Ophthalmic Solution Vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days
Closest Location: Lexitas · Durham, NC
Photo of durham 1Photo of durham 2Photo of durham 3
2021First Recorded Clinical Trial
2 TrialsResearching Dry Eye Syndromes
1 CompletedClinical Trials

Who is running the clinical trial?

Seinda Pharmaceutical Guangzhou CorporationLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
You have a BCVA in each eye, using corrective lenses if necessary, of +0.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.