Safety and Comfort of AL-4943A Ophthalmic Solution

A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%

The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

Inclusion Criteria:

• Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
• Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
• History of any clinically significant external ocular disease within 30 days of the start of the study.
• Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.
• Other protocol-defined exclusion criteria may apply.