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

Phase 1 & 2
Waitlist Available
Research Sponsored by Seinda Pharmaceutical Guangzhou Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days

Summary

This trial is testing an eye drop treatment called SY-201 Ophthalmic Solution. It aims to see if the eye drops are safe and effective for people who have dry eye disease. The study will compare the eye drops to another group over a few months.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60
Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60
Secondary study objectives
Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60
Change From Baseline in Symptom Severity Score (Subscale) at Day 60

Side effects data

From 2023 Phase 1 & 2 trial • 201 Patients • NCT05370495
10%
Instillation site irritation
6%
Eye Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution Vehicle

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SY-201 Ophthalmic Solution 2.0%Experimental Treatment1 Intervention
SY-201 Ophthalmic Solution 2.0%
Group II: SY-201 Ophthalmic Solution 1.0%Experimental Treatment1 Intervention
SY-201 Ophthalmic Solution 1.0%
Group III: SY-201 Ophthalmic Solution 0.5%Experimental Treatment1 Intervention
SY-201 Ophthalmic Solution 0.5%
Group IV: SY-201 Ophthalmic Solution VehiclePlacebo Group1 Intervention
SY-201 Ophthalmic Solution Vehicle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SY-201 Ophthalmic Solution 2.0%
2022
Completed Phase 2
~210
SY-201 Ophthalmic Solution 0.5%
2022
Completed Phase 2
~210
SY-201 Ophthalmic Solution 1.0%
2022
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

Seinda Pharmaceutical Guangzhou CorporationLead Sponsor
~60 spots leftby Dec 2025
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