An Evaluation of the Safety and Tolerability of Ocular Lubricants

Alcon

Status: Begins enrollment this month

Conditions: Dry Eye Disease

Treatments: Other: FID123440 test formulation; Other: FID123437 test formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07238699

DEE253-E003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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148 participants in 2 patient groups

Sequence 1: FID123440, then FID123437

Experimental group

Description:

One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Treatment:

Other: FID123437 test formulation

Other: FID123440 test formulation

Other: FID123440 test formulation

Sequence 2: FID123437, then FID123440

Experimental group

Description:

One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.

Treatment:

Other: FID123437 test formulation

Other: FID123440 test formulation

Other: FID123440 test formulation