Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: SCAI-001 0.01% eyedrop
* Drug: SCAI-001 0.02% eyedrop
* Drug: Restasis 0.05% eyedrop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCAI-001 0.01%<br>Cyclosporine 0.01% | Drug: SCAI-001 0.01% eyedrop<br>* BID for 12weeks<br>* Other names: Cyclosporine 0.01%;|
| Experimental: SCAI-001 0.02%<br>Cyclosporine 0.02% | Drug: SCAI-001 0.02% eyedrop<br>* BID for 12weeks<br>* Other names: Cyclosporine 0.02%;|
| Active Comparator: Restasis<br>Cyclosporine 0.05% | Drug: Restasis 0.05% eyedrop<br>* BID for 12weeks<br>* Other names: Cyclosporine 0.05%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear volume | Schirmer's test | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear volume | Schirmer's test | Change from baseline at 4, 8 weeks | 
| Corneal staining score with fluorescein | Oxford grading | Change from baseline at 4, 8, 12 weeks | 
| conjunctival staining score with Lissamine green | Oxford grading | Change from baseline at 4, 8, 12 weeks | 
| Tear film break-up time | Measured three times and recorded up to 1/100 | Change from baseline at 4, 8, 12 weeks | 
| Standard patient evaluation of eye dryness questionnaire | written by the subject | Change from baseline at 4, 8, 12 weeks | 
| Ocular surface disease index | written by the subject | Change from baseline at 4, 8, 12 weeks | 
| Total number of rescue medication used | sourced by patient diary | 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Cyclosporine