An Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness

A Multicenter Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ocular Hyperemia
• Intervention / Treatment: Drug: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free; Drug: Vehicle

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alcon Call Center; Phone Number: 1-888-451-3937; Email: alcon.medinfo@alcon.com

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Capable of giving signed informed consent and complying 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 has an interest in using redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion.
• Best corrected visual acuity at distance of 0.3 logarithm Minimum Angle of Resolution or better in each eye.
• Baseline ocular redness score greater than 1 unit in both eyes using the 0-4 Ora Calibra® Ocular Hyperemia Scale.
• Stable ocular health.
• 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.
• Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters.
• Use of prohibited medications, devices, or treatments as specified in the protocol;
• Ocular or systemic conditions or situations which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
• Currently pregnant or breastfeeding; planning a pregnancy or planning to breastfeed during the study; has a positive urine pregnancy test during screening at Visit 1 or Visit 2.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free; One drop in each eye on Day 1 (single dose)	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; Other Names: FID 123472; Apraclonidine 0.125% UDPF
Placebo Comparator: Vehicle; One drop in each eye on Day 1 (single dose)	Drug: Vehicle; Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 15 minutes post-instillation on 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.	Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on 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.	Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 1 minute post-instillation on 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).	Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)
Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on 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).	Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Pharma, Alcon Research, LLC

Publications and helpful links

Helpful Links

• Educational

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ocular Redness
• Additional Relevant MeSH Terms: apraclonidine
• Other Study ID Numbers: DEW261-C002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No