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

NCT05370495 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2024-11-26

Study results available
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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).

Conditions

Interventions

DRUG

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 2.0%

DRUG

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 1.0%

DRUG

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution 0.5%

DRUG

SY-201 Ophthalmic Solution Vehicle

SY-201 Ophthalmic Solution Vehicle

Sponsors & Collaborators

  • Seinda Pharmaceutical Guangzhou Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2023-03-24
Completion
2023-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05370495 on ClinicalTrials.gov