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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370495
• Other study ID #: SY201-CS201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 25, 2022
• Est. completion date: March 24, 2023

Study information

• Verified date: November 2023
• Source: Seinda Pharmaceutical Guangzhou Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• 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 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 [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 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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• SY-201 Ophthalmic Solution 2.0%
SY-201 Ophthalmic Solution 2.0%
• SY-201 Ophthalmic Solution 1.0%
SY-201 Ophthalmic Solution 1.0%
• SY-201 Ophthalmic Solution 0.5%
SY-201 Ophthalmic Solution 0.5%
• SY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle

Locations

Country	Name	City	State
United States	Lexitas	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Seinda Pharmaceutical Guangzhou Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total corneal fluorescein staining	As measured by modified National Eye Institute scale (0 (none) to 20 (severe))	60 days
Primary	Eye dryness score	As measure by visual analog scale (0 (none) to 100 (severe))	60 days
Secondary	Adverse event	Frequency and severity of ocular and non-ocular adverse events	60 days