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

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

• Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) [Time frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3) [Time frame: Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)]

Secondary outcome measures (2)

• Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) [Time frame: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)]
• Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3) [Time frame: Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)]

Eligibility criteria

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 greater than 1 on a 5-point scale in both eyes prior to randomization on Day 1 (Visit 2).
• Other protocol-defined inclusion criteria may apply.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Contact Alcon Call Center for Trial Locations — Fort Worth

Identifiers

NCT: NCT07531043 · DEW261-C002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗