An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults

A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects

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

Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation 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 ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol.
• Ocular surgical interventions 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 parameters.
• Use of prohibited medications, devices, or treatments as specified in the 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.