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

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

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 Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: SY-201 Ophthalmic Solution 2.0%; Drug: SY-201 Ophthalmic Solution 1.0%; Drug: SY-201 Ophthalmic Solution 0.5%; Drug: SY-201 Ophthalmic Solution Vehicle

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lexitas Clinical Trials; Phone Number: (919) 205-0012; Email: clinicaltrials@lexitas.com

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Lexitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SY-201 Ophthalmic Solution 2.0%	Drug: SY-201 Ophthalmic Solution 2.0%; SY-201 Ophthalmic Solution 2.0%
Experimental: SY-201 Ophthalmic Solution 1.0%	Drug: SY-201 Ophthalmic Solution 1.0%; SY-201 Ophthalmic Solution 1.0%
Experimental: SY-201 Ophthalmic Solution 0.5%	Drug: SY-201 Ophthalmic Solution 0.5%; SY-201 Ophthalmic Solution 0.5%
Placebo Comparator: SY-201 Ophthalmic Solution Vehicle	Drug: SY-201 Ophthalmic Solution Vehicle; SY-201 Ophthalmic Solution Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total corneal fluorescein staining	As measured by modified National Eye Institute scale (0 (none) to 20 (severe))	60 days
Eye dryness score	As measure by visual analog scale (0 (none) to 100 (severe))	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Frequency and severity of ocular and non-ocular adverse events	60 days

Collaborators and Investigators

• Sponsor: Seinda Pharmaceutical Guangzhou Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: SY201-CS201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No