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;