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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2023-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

NCT01468168

Dry Eye Disease

COMPLETED PHASE2

A Multi-Center Study Subjects With Dry Eye Syndrome

NCT01745887

Dry Eye Syndrome

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Efficacy of A197 in Subjects With Dry Eye Disease

NCT05238597

Dry Eye Disease

COMPLETED PHASE2

A Study of RX-10045 in the Treatment of Dry Eye Disease

NCT01675570

Dry Eye Syndrome

COMPLETED PHASE2

NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

NCT00739349

Dry Eye

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-masked, parallel, randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SY-201 Ophthalmic Solution 2.0%

Group Type EXPERIMENTAL

SY-201 Ophthalmic Solution 2.0%

Intervention Type DRUG

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

Group Type EXPERIMENTAL

SY-201 Ophthalmic Solution 1.0%

Intervention Type DRUG

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

Group Type EXPERIMENTAL

SY-201 Ophthalmic Solution 0.5%

Intervention Type DRUG

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

Group Type PLACEBO_COMPARATOR

SY-201 Ophthalmic Solution Vehicle

Intervention Type DRUG

SY-201 Ophthalmic Solution Vehicle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SY-201 Ophthalmic Solution 2.0%

Intervention Type DRUG

SY-201 Ophthalmic Solution 1.0%

Intervention Type DRUG

SY-201 Ophthalmic Solution 0.5%

Intervention Type DRUG

SY-201 Ophthalmic Solution Vehicle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No