Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis
- Conditions
- Dry Eye Syndromes
- Interventions
- Registration Number
- NCT05733624
- Lead Sponsor
- SCAI Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCAI-001 0.01% SCAI-001 0.01% eyedrop Cyclosporine 0.01% SCAI-001 0.02% SCAI-001 0.02% eyedrop Cyclosporine 0.02% Restasis Restasis 0.05% eyedrop Cyclosporine 0.05%
- Primary Outcome Measures
Name Time Method Tear volume Change from baseline at 12 weeks Schirmer's test
- Secondary Outcome Measures
Name Time Method Tear volume Change from baseline at 4, 8 weeks Schirmer's test
Total number of rescue medication used 12weeks sourced by patient diary
Corneal staining score with fluorescein Change from baseline at 4, 8, 12 weeks Oxford grading
conjunctival staining score with Lissamine green Change from baseline at 4, 8, 12 weeks Oxford grading
Tear film break-up time Change from baseline at 4, 8, 12 weeks Measured three times and recorded up to 1/100
Standard patient evaluation of eye dryness questionnaire Change from baseline at 4, 8, 12 weeks written by the subject
Ocular surface disease index Change from baseline at 4, 8, 12 weeks written by the subject
Trial Locations
- Locations (11)
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of korea, Bucheon ST.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Pusan National Univ. Hospital
🇰🇷Busan, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of