Back to results

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

Primary Purpose

Dry Eye Disease

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1.
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
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.
Have a history of glaucoma or IOP >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye.
Wear contact lenses for 14 days prior to Visit 1 or throughout the study.

Sites / Locations

LexitasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

Arm Description

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

Outcomes

Primary Outcome Measures

Total corneal fluorescein staining

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

Eye dryness score

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

Secondary Outcome Measures

Adverse event

Frequency and severity of ocular and non-ocular adverse events

Full Information

NCT ID

NCT05370495

First Posted

May 6, 2022

Last Updated

July 27, 2022

Sponsor

Seinda Pharmaceutical Guangzhou Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05370495

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 25, 2022 (Actual)

Primary Completion Date

July 25, 2023 (Anticipated)

Study Completion Date

July 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seinda Pharmaceutical Guangzhou Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Double-masked, parallel, randomized

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SY-201 Ophthalmic Solution 2.0%

Arm Type

Experimental

Arm Description

SY-201 Ophthalmic Solution 2.0%

Arm Title

SY-201 Ophthalmic Solution 1.0%

Arm Type

Experimental

Arm Description

SY-201 Ophthalmic Solution 1.0%

Arm Title

SY-201 Ophthalmic Solution 0.5%

Arm Type

Experimental

Arm Description

SY-201 Ophthalmic Solution 0.5%

Arm Title

SY-201 Ophthalmic Solution Vehicle

Arm Type

Placebo Comparator

Arm Description

SY-201 Ophthalmic Solution Vehicle

Intervention Type

Drug

Intervention Name(s)

SY-201 Ophthalmic Solution 2.0%

Intervention Description

SY-201 Ophthalmic Solution 2.0%

Intervention Type

Drug

Intervention Name(s)

SY-201 Ophthalmic Solution 1.0%

Intervention Description

SY-201 Ophthalmic Solution 1.0%

Intervention Type

Drug

Intervention Name(s)

SY-201 Ophthalmic Solution 0.5%

Intervention Description

SY-201 Ophthalmic Solution 0.5%

Intervention Type

Drug

Intervention Name(s)

SY-201 Ophthalmic Solution Vehicle

Intervention Description

SY-201 Ophthalmic Solution Vehicle

Primary Outcome Measure Information:

Title

Total corneal fluorescein staining

Description

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

Time Frame

60 days

Title

Eye dryness score

Description

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

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Adverse event

Description

Frequency and severity of ocular and non-ocular adverse events

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Provide written informed consent prior to any study-related procedures. Are 18 years of age or older. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study. 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: Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1. 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 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. Have a history of glaucoma or IOP >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lexitas Clinical Trials

Phone

(919) 205-0012

clinicaltrials@lexitas.com

Facility Information:

Facility Name

Lexitas

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27703

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing-Feng Huang, Ph.D.

Phone

919-205-0012

SY201@seindapharm.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs