Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults

A Two-Arm Multicenter Clinical Trial to Investigate Efficacy and Safety of FID123472 Ophthalmic Solution Compared With Vehicle in Adult Subjects With Ocular Redness

The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.

Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.

Key Inclusion Criteria:

• Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form.
• Willing and able to follow all instructions and attend all study visits.
• History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
• Baseline investigator-assessed ocular redness score of 0.5 or higher in at least one eye at Visit 1 when applicable and a score of greater than 1.0 in both eyes on a 5-point scale prior to randomization on Day 1 (Visit 2).
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol.
• Ocular surgical intervention within 6 months prior to Visit 1 or during the study.
• Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters.
• Use of any of the prohibited medications or devices as specified in the study protocol.
• Out-of-range vital signs (blood pressure and/or pulse rate) as defined in the study protocol.
• Abnormal intraocular pressure.
• Other protocol-defined exclusion criteria may apply.