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

SCAI Therapeutics

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Drug: SCAI-001 0.01% eyedrop; Drug: Restasis 0.05% eyedrop; Drug: SCAI-001 0.02% eyedrop

Study type: Interventional

Funder types: Industry

Identifiers

NCT05733624

SCAI-001-201

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 3 patient groups

SCAI-001 0.01%

Experimental group

Description:

Cyclosporine 0.01%

Treatment:

Drug: SCAI-001 0.01% eyedrop

SCAI-001 0.02%

Experimental group

Description:

Cyclosporine 0.02%

Treatment:

Drug: SCAI-001 0.02% eyedrop

Restasis

Active Comparator group

Description:

Cyclosporine 0.05%

Treatment:

Drug: Restasis 0.05% eyedrop