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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2024-02-02

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.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SCAI-001 0.01%

Cyclosporine 0.01%

Group Type EXPERIMENTAL

SCAI-001 0.01% eyedrop

Intervention Type DRUG

BID for 12weeks

SCAI-001 0.02%

Cyclosporine 0.02%

Group Type EXPERIMENTAL

SCAI-001 0.02% eyedrop

Intervention Type DRUG

BID for 12weeks

Restasis

Cyclosporine 0.05%

Group Type ACTIVE_COMPARATOR

Restasis 0.05% eyedrop

Intervention Type DRUG

BID for 12weeks

Interventions

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SCAI-001 0.01% eyedrop

BID for 12weeks

Intervention Type DRUG

SCAI-001 0.02% eyedrop

BID for 12weeks

Intervention Type DRUG

Restasis 0.05% eyedrop

BID for 12weeks

Intervention Type DRUG

Other Intervention Names

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Cyclosporine 0.01% Cyclosporine 0.02% Cyclosporine 0.05%

Eligibility Criteria

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Inclusion Criteria

1. Male and Female who over 19 years old
2. Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
3. 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.
4. The corrected visual acuity is 0.2 or more.

Exclusion Criteria

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No