The purpose of this study is to explore the efficacy and safety of CsA ophthalmic gel in the treatment of moderate to severe tear deficiency dry eye with different dosage, frequency and concentration, and to preliminarily determine the optimal dosage, frequency and concentration, so as to provide a theoretical basis for the design of follow-up clinical studies.
A multicenter, randomized, single-blind, positive controlled exploratory study will be conducted with cyclosporine A ophthalmic emulsion as the control drug. The experimental drugs were divided into three groups: Treatment group A: CsA eye gel: 0.3 g: 0.15 mg, once daily; Treatment group B: CsA eye gel: 0.3 g: 0.15 mg, twice daily, interval of about 12 hours; Treatment group C: CsA eye gel: 0.3 g: 0.3 mg, once daily. One drop into each eye when you use it. Control group: CsA emulsion: 0.4 ml: 0.2 mg. One drop into the eye, 2 times daily with an interval for 12 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
The CsA for eye emulsion of 0.4 ml: 0.2 mg
Hypromellose Eye Drops of 15ml:75mg, 3 times daily, 1-2 drop
Ophthalmological Center of Zhongshan University
Guangzhou, Guangdong, China
The EDS score at the NO.5 visit was compared with the baseline EDS score (binocular)
0-100 points VAS score was evaluated
Time frame: 84 days after admission
The EDS score at the NO.3, NO.4 visit were compared with the baseline EDS score (binocular)
0-100 points VAS score was evaluated
Time frame: 14 days after admission ,42days after admission
Average changes in VAS scores of 6 dry eye symptoms (burning/needling sensation, pruritus, foreign body sensation, discomfort, photophobia and pain) at the NO.3, NO.4 and NO.5 visit were compared with baseline (binocular)
0-100 points VAS score was evaluated
Time frame: 14 days after admission ,42 days after admission ,84days days after admission
Comparison of the NO.3, NO.4, NO.5 visit and baseline corneal fluorescein staining changes
score(The cornea was divided into five quadrants: central, upper, lower, temporal and nasal. The cornea was stained with 4 points, 0 points for non-staining, 1 point for scattered dotted staining, 2 points for clan staining, 3 points for local dense + scattered dotted staining and 4 points for extensive diffuse staining. The total score is the sum of the quadrant scores)
Time frame: 14 days after admission ,42 days after admission ,84 days after admission
Comparison of the NO.3, NO.4, NO.5 visit and baseline BUT changes
time
Time frame: 14 days after admission ,42 days after admission ,84 days after admission
Comparison of the NO.3, NO.4, NO.5 visit and baseline Schirmer changes
Basal tear secretion
Time frame: 14 days after admission ,42 days after admission ,84 days after admission
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