This study is a multicenter, randomized, double-blind, placebo-controlled, superiority design Phase III clinical trial. The primary objective is to evaluate the efficacy and safety of cyclosporine ophthalmic gel versus placebo in the treatment of moderate to severe dry eye for 84 days.
aged ≥ 18 years old, males or females.
Subjects complained of ocular dryness in both eyes for at least 6 months at Visit 1.
Eye dryness score(EDS)(evaluated on a 0-100 VAS score) ≥40 at Visit 1 and Visit 2.
Ocular Surface Disease Index (OSDI) score ≥13 at Visit 1 and Visit 2.
Subjects with severe dry eye requiring surgical treatment.
Systemic use of retinoids within the 12 months prior to Visit 1.
Subjects who have had intraocular surgery within 12 months prior to Visit 1 or who require intraocular surgery during the study; or subjects who have had eyelid surgery within 6 months prior to Visit 1.
Subjects treated with permanent lacrimal duct embolization; or subjects treated with temporary lacrimal duct embolization within 6 months prior to Visit 1.
Parallel
Cyclosporine ophthalmic gel
DrugAdminister to eyes
Cyclosporine ophthalmic gel vehicle
DrugAdminister to eyes
Eye Dryness Score(EDS)
Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 84 (binocular)
Eye Dryness Score(EDS)
Mean change from baseline in EDS scores (evaluated on a 0-100 VAS score) on Day 14 and Day 42 (binocular)
Total VAS score for dry eye symptoms
Mean change from baseline in total VAS score of dry eye symptoms (evaluated on a 0-100 VAS score) on Day 14, Day 42 and Day 84 (binocular)
Total corneal fluorescein staining score(tCFS)
The proportion of subjects with a total corneal fluorescein staining score (tCFS, modified NEI scale) of 0 on Day 14, Day 42, and Day 84 (study eye)
Schirmer test
The proportion of subjects with a change of ≥ 10mm from baseline in the Schirmer test (tear secretion test) on Day 14, Day 42, and Day 84 (study eye)
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