This is a phase III, multicenter, randomized, double-masked, Active-controlled design. The aims to confirm previous findings of the efficacy and safety of CsA-PG Ophthalmic Gel by comparing it to CsA Ophthalmic Gel for treating dry eye symptoms.
Be at least 18 years of age, male or female;
Provide written informed consent;
Have a reported history of dry eye for at least 6 months before Visit 1;
Have a clinical diagnosis of bilateral dry eye disease, including all of the following scored in at least one eye at both Visits 1 and 2;
Clinical diagnosis or history of any clinically significant ocular diseases/disorders (e.g., age-related maculopathy that requires treatment and/or in the opinion of the Investigator may interfere with study parameters in Visit 1 and/or Visit 2;
Any active ocular or systemic infection (e.g., bacterial, viral, or fungal) at Visit 1 and/or Visit 2;
Any active ocular inflammation (e.g., iritis, uveitis, allergic conjunctivitis) at Visit 1 and/or Visit 2;
Any conjunctival scarring history (Such as with irradiation, alkali burns, Steven Johnson syndrome, Sjogren's syndrome, cicatricial pemphigoid) or destruction of conjunctival goblet cells (e.g., neurotrophic keratitis, vitamin A deficiency) before Visit 1;
Parallel
CsA-PG Ophthalmic Gel
DrugAdminister to eyes
CsA Ophthalmic Gel
DrugAdminister to eyes
Eye Dryness Score(EDS)
The mean change from baseline in EDS (Eye Dryness Score) at the 84 days , with EDS assessment performed using a Visual Analogue Scale (VAS). The VAS score employs a 0 to 100-point scale (0 = no symptoms; 100 = extreme severity/intolerable discomfort), where higher scores indicate greater symptom severity.
Total Corneal Staining Score(TCSS)
The proportion of patients achieving complete resolution of total corneal staining (TCSS= 0 ) at Day 84.TCSS is scored on a 0-to-20-point scale, higher numerical values correlate with increased severity of corneal damage.
Schirmer Tear Test (STT)
At day 84, the proportion of patients improved by ≥ 10 mm from baseline.
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