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

NCT07531043 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: DEW261-C002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Hyperemia

Keywords

Ocular Redness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean change from baseline (pretreatment) in investigator-assessed ocular redness at 1 minute post-instillation on Day 1

  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

  Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)

Study Arms (2)

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

EXPERIMENTAL

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

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

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

Vehicle DRUG

Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

Vehicle

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free DRUG

Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation

Also known as: FID 123472, Apraclonidine 0.125% UDPF

Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Related Links

• Educational

MeSH Terms

Interventions

apraclonidine

Study Officials

• Clinical Trial Lead, Pharma

  Alcon Research, LLC

  STUDY DIRECTOR

Central Study Contacts

Alcon Call Center

CONTACT

1-888-451-3937; alcon.medinfo@alcon.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)