A Multicenter, Active Control, Parallel Group, Randomized, Double-blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops in Patients With Dry Eye Disease

SCAI Therapeutics11 sites in 1 country116 target enrollmentJanuary 5, 2023

ConditionsDry Eye Syndromes

InterventionsSCAI-001 0.01% eyedrop SCAI-001 0.02% eyedrop Restasis 0.05% eyedrop

DrugsSCAI-001 0.01% eyedrop SCAI-001 0.02% eyedrop Restasis 0.05% eyedrop

Overview

Phase: Phase 2
Intervention: SCAI-001 0.01% eyedrop
Conditions: Dry Eye Syndromes
Sponsor: SCAI Therapeutics
Enrollment: 116
Locations: 11
Primary Endpoint: Tear volume
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is planned to Evaluate the Efficacy and Safety of SCAI-001 Eye Drops(Cyclosporine 0.01%, 0.02%) compared to Restasis(Cyclosporine 0.05%) in Patients with Dry Eye Disease.

Registry

clinicaltrials.gov

Start Date

January 5, 2023

End Date

February 2, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SCAI Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and Female who over 19 years old
•Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
•Those who meet below criteria at least one of two eyes;
•Those who have over than score 2 in corneal staining test-Oxford grading
•Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
•TBUT(Tear film break-up time) test result should be under 10sec.
•The corrected visual acuity is 0.2 or more.

Exclusion Criteria

•Those who have clinically significant eye disease not related to dry eye syndrome
•Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit
•Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
•Those who have medical history with intraocular surgery 12months before screening visit
•Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes
•Those who have medicated cyclosporine eye-drops 6weeks before screening visit
•Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
•Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
•Those who have received other investigational drugs/devices 30 days before screening visit
•Those who are inappropriate for participating in this study according to investigator's judgement

Arms & Interventions

SCAI-001 0.01%

Cyclosporine 0.01%

Intervention: SCAI-001 0.01% eyedrop

SCAI-001 0.02%

Cyclosporine 0.02%

Intervention: SCAI-001 0.02% eyedrop

Restasis

Cyclosporine 0.05%

Intervention: Restasis 0.05% eyedrop

Outcomes

Primary Outcomes

Tear volume

Time Frame: Change from baseline at 12 weeks

Schirmer's test

Secondary Outcomes

Tear volume(Change from baseline at 4, 8 weeks)
Total number of rescue medication used(12weeks)
Corneal staining score with fluorescein(Change from baseline at 4, 8, 12 weeks)
conjunctival staining score with Lissamine green(Change from baseline at 4, 8, 12 weeks)
Tear film break-up time(Change from baseline at 4, 8, 12 weeks)
Standard patient evaluation of eye dryness questionnaire(Change from baseline at 4, 8, 12 weeks)
Ocular surface disease index(Change from baseline at 4, 8, 12 weeks)