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Completed

NCT Number: NCT05370495

Study of SY-201 Ophthalmic Solution 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).

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lexitas

Durham, North Carolina, 27703, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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 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

  • 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 [National Eye Institute (NEI) grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
  • 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.
  • Wear contact lenses for 14 days prior to Visit 1 or throughout the study.

Treatment and study plan

SY-201 Ophthalmic Solution 2.0%

Drug

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

Drug

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

Drug

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

Drug

SY-201 Ophthalmic Solution Vehicle

Primary outcomes

  1. Change From Baseline in Total Corneal Fluorescein Staining (tCFS) at Day 60

    Time frame: 60 days

    Cornea is divided into 5 regions and each region is stained and graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)). Total corneal fluorescein staining score is the sum of the scores from 5 regions (0 -20).

  2. Change From Baseline in Eye Dryness Score (Visual Analog Scale) at Day 60

    Time frame: 60 days

    Eye dryness score as measure by visual analog scale (0 (none) to 100 (severe)) was used to as efficacy meaure for dry eye symptom improvement. This outcome measure focused on self reported extent of eye dryness.

Secondary outcomes

  1. Change From Baseline in Central Corneal Fluorescein Staining (cCFS) at Day 60

    Time frame: 60 days

    Cornea is divided into 5 regions. The central region is graded from 0 - 4 (modified National Eye Institute scale (0 (none) to 4 (severe)).

  2. Change From Baseline in Symptom Severity Score (Subscale) at Day 60

    Time frame: 60 days

    Symptom severity score sub scale is measured of severity scale of symptoms associated with dry eye using visual analog scale (0 (none) -100 (severe)). This self reported Dry eye symptoms severity score sub scale measures the extent of any ocular discomfort (symptoms), including but not limited to dryness, ocular pain or other type of symptoms.

Sponsors and collaborators

Lead sponsor

Seinda Pharmaceutical Guangzhou Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 11, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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