The purpose of this clinical Study is TJCS Eye Drops 0.05%(Cyclosporine ophthalmic nano-emulsion) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
158
1 drop twice/day for 12 weeks to both eyes.
1 drop twice/day for 12 weeks to both eyes. Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Corneal staining test
Time frame: 12 weeks
Corneal staining test
Time frame: 4, 8 weeks
Conjunctival staining
Time frame: 4, 8, 12 weeks
Corneal and Conjunctival staining sum Score
Time frame: 4, 8, 12 weeks
Ocular surface disease index (OSDI)
Time frame: 4, 8, 12 weeks
Tear break up time (TBUT)
Time frame: 4, 8, 12 weeks
Non-anesthetic Schirmer test
Time frame: 4, 8, 12 weeks
Frequency of concurrent drug use
Time frame: 4, 8, 12 weeks
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