Dry Eye Syndromes
Conditions
Keywords
Dry Eye, Cyclosporine
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.
Interventions
DRUGSCAI-001 0.01% eyedrop
BID for 12weeks
DRUGSCAI-001 0.02% eyedrop
BID for 12weeks
DRUGRestasis 0.05% eyedrop
BID for 12weeks
Sponsors
SCAI Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear volume | Change from baseline at 12 weeks | Schirmer's test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Tear volume | Change from baseline at 4, 8 weeks | Schirmer's test |
| Ocular surface disease index | Change from baseline at 4, 8, 12 weeks | written by the subject |
| Total number of rescue medication used | 12weeks | sourced by patient diary |
| Standard patient evaluation of eye dryness questionnaire | Change from baseline at 4, 8, 12 weeks | written by the subject |
Countries
South Korea
Outcome results
None listed