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

NCT05370495 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SY201-CS201
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

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

  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).

  60 days

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

  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.

  60 days

Secondary Outcomes (2)

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

  60 days

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

  60 days

Study Arms (4)

SY-201 Ophthalmic Solution 2.0%

EXPERIMENTAL

SY-201 Ophthalmic Solution 2.0%

Drug: SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

EXPERIMENTAL

SY-201 Ophthalmic Solution 1.0%

Drug: SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

EXPERIMENTAL

SY-201 Ophthalmic Solution 0.5%

Drug: SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

SY-201 Ophthalmic Solution Vehicle

Drug: SY-201 Ophthalmic Solution Vehicle

Interventions

SY-201 Ophthalmic Solution 2.0% DRUG

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0% DRUG

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5% DRUG

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle DRUG

SY-201 Ophthalmic Solution Vehicle

SY-201 Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seinda Pharmaceutical Guangzhou Corporation: lead

Study Sites (1)

Lexitas

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jing-Feng Huang, Ph.D.
• Organization: Seinda

jfhuang@SeindaPharm.com

1.858.254.9188

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked, parallel, randomized

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: July 25, 2022
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)