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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
116
BID for 12weeks
BID for 12weeks
BID for 12weeks
The Catholic University of korea, Bucheon ST.Mary's Hospital
Bucheon-si, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Pusan National Univ. Hospital
Busan, South Korea
Tear volume
Schirmer's test
Time frame: Change from baseline at 12 weeks
Tear volume
Schirmer's test
Time frame: Change from baseline at 4, 8 weeks
Corneal staining score with fluorescein
Oxford grading
Time frame: Change from baseline at 4, 8, 12 weeks
conjunctival staining score with Lissamine green
Oxford grading
Time frame: Change from baseline at 4, 8, 12 weeks
Tear film break-up time
Measured three times and recorded up to 1/100
Time frame: Change from baseline at 4, 8, 12 weeks
Standard patient evaluation of eye dryness questionnaire
written by the subject
Time frame: Change from baseline at 4, 8, 12 weeks
Ocular surface disease index
written by the subject
Time frame: Change from baseline at 4, 8, 12 weeks
Total number of rescue medication used
sourced by patient diary
Time frame: 12weeks
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Kyungpook National University Hospital
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, South Korea
...and 1 more locations