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

Sponsor
Seinda Pharmaceutical Guangzhou Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05370495
Collaborator
(none)
200
Enrollment
1
Location
4
Arms
12
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-masked, parallel, randomizedDouble-masked, parallel, randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Jul 25, 2023
Anticipated Study Completion Date :
Jul 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SY-201 Ophthalmic Solution 2.0%

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%

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%

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

SY-201 Ophthalmic Solution Vehicle

Drug: SY-201 Ophthalmic Solution Vehicle
SY-201 Ophthalmic Solution Vehicle

Outcome Measures

Primary Outcome Measures

  1. Total corneal fluorescein staining [60 days]

    As measured by modified National Eye Institute scale (0 (none) to 20 (severe))

  2. Eye dryness score [60 days]

    As measure by visual analog scale (0 (none) to 100 (severe))

Secondary Outcome Measures

  1. Adverse event [60 days]

    Frequency and severity of ocular and non-ocular adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lexitas Durham North Carolina United States 27703

Sponsors and Collaborators

  • Seinda Pharmaceutical Guangzhou Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seinda Pharmaceutical Guangzhou Corporation
ClinicalTrials.gov Identifier:
NCT05370495
Other Study ID Numbers:
  • SY201-CS201
First Posted:
May 11, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions

Study Results

No Results Posted as of Aug 1, 2022