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.