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

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.

• Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free (Drug), also known as FID 123472, Apraclonidine 0.125% UDPF: Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
• Vehicle (Drug): Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

Primary outcomes

• Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) [Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)]: Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.
• Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3) [Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)]: Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint.

Secondary outcomes

• Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) [Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)]: Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).
• Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3) [Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)]: Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity).

Sex: All, ages: 18 Years to any

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.