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

ClinicalTrials.gov ID: NCT05370495

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT05370495
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Seinda Pharmaceutical Guangzhou Corporation; Industry
Enrollment: 201 participants

Conditions and interventions

Conditions

Dry Eye Disease

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 99 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 25, 2022 (Actual)
Primary completion: Mar 24, 2023 (Actual)
Completion: Mar 24, 2023 (Actual)
Last update posted: Nov 26, 2024

2022 – 2023

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Lexitas	Durham	North Carolina	27703	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05370495, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 26, 2024 · Synced Nov 15, 2026