An Evaluation of the Safety and Tolerability of Ocular Lubricants

An Evaluation of the Safety and Tolerability of Ocular Lubricants

The purpose of this study is to evaluate the safety and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.

Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.

Inclusion Criteria:

• Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
• Subject must be willing and able to attend all study visits as required by the protocol.
• Subject must exhibit symptoms of dry eye at the Screening Visit.
• Subject must currently use artificial tears.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Has any known active ocular disease and/or infection.
• Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
• Any ocular injury to either eye in the 12 weeks prior to screening.
• Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
• Other protocol-defined exclusion criteria may apply.