---
title: Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease
nct_id: NCT05370495
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Seinda Pharmaceutical Guangzhou Corporation
study_type: INTERVENTIONAL
primary_condition: Dry Eye Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05370495.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05370495"
ct_last_update_post_date: 2024-11-26
last_seen_at: "2026-05-12T06:26:46.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

**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

**NCT ID:** [NCT05370495](https://clinicaltrials.gov/study/NCT05370495)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 201
- **Lead Sponsor:** Seinda Pharmaceutical Guangzhou Corporation
- **Conditions:** Dry Eye Disease
- **Start Date:** 2022-07-25
- **Completion Date:** 2023-03-24
- **CT.gov Last Update:** 2024-11-26

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
* Inclusion Criteria

  1. Provide written informed consent prior to any study-related procedures.
  2. Are 18 years of age or older.
  3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
  4. Have a Best Corrected Visual Acuity (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:

1. Unanesthetized Schirmer test score in either eye \<2 mm/5 minutes at Visit 1.
2. 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
3. Have corneal erosive disease (e.g., confluent staining \[National Eye Institute (NEI) grade 4\], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
4. Have a history of glaucoma or intraocular pressure (IOP) \>25 mmHg at Visit 1 or a history of elevated IOP (\>25 mmHg) in either eye.
5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.
```

## Arms

- **SY-201 Ophthalmic Solution 2.0%** (EXPERIMENTAL) — SY-201 Ophthalmic Solution 2.0%
- **SY-201 Ophthalmic Solution 1.0%** (EXPERIMENTAL) — SY-201 Ophthalmic Solution 1.0%
- **SY-201 Ophthalmic Solution 0.5%** (EXPERIMENTAL) — SY-201 Ophthalmic Solution 0.5%
- **SY-201 Ophthalmic Solution Vehicle** (PLACEBO_COMPARATOR) — SY-201 Ophthalmic Solution Vehicle

## Interventions

- **SY-201 Ophthalmic Solution 2.0%** (DRUG) — SY-201 Ophthalmic Solution 2.0%
- **SY-201 Ophthalmic Solution 1.0%** (DRUG) — SY-201 Ophthalmic Solution 1.0%
- **SY-201 Ophthalmic Solution 0.5%** (DRUG) — SY-201 Ophthalmic Solution 0.5%
- **SY-201 Ophthalmic Solution Vehicle** (DRUG) — SY-201 Ophthalmic Solution Vehicle

## Primary Outcomes

- **Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60** _(time frame: 60 days)_ — Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).
- **Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60** _(time frame: 60 days)_ — Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.

## Secondary Outcomes

- **Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60** _(time frame: 60 days)_
- **Change From Baseline in Symptom Severity Score (Subscale) at Day 60** _(time frame: 60 days)_

## Locations (1)

- Lexitas, Durham, North Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.lexitas|durham|north carolina|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05370495*  
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