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

Alcon

Status and phase: Begins enrollment this month; Phase 3

Conditions: Ocular Hyperemia

Treatments: Drug: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT07531043

DEW261-C002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups, including a placebo group

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

Experimental group

Description:

One drop in each eye on Day 1 (single dose)

Treatment:

Drug: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

Vehicle

Placebo Comparator group

Description:

One drop in each eye on Day 1 (single dose)

Treatment:

Drug: Vehicle