A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

NCT06444529 | Completed Phase 3 FDA Drug

• 1 other identifier: DEW422-C001
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.

Conditions

Ocular Redness

Keywords

Eye redness; Irritated eyes

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1

  Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.

  Day 1: Pretreatment; 15 minutes post-treatment

• Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1

  Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.

  Day 1: Pretreatment; 10 hours (600 minutes) post-treatment

Secondary Outcomes (3)

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

  Day 1: Pretreatment; 1 minute post-treatment

• Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1

  Day 1: Pretreatment; 8 hours (480 minutes) post-treatment

• Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1

  Day 1: Pretreatment; 12 hours (720 minutes) post-treatment

Study Arms (2)

Apraclonidine Hydrochloride Ophthalmic Solution

EXPERIMENTAL

One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks

Drug: Apraclonidine Hydrochloride Ophthalmic Solution

Vehicle

PLACEBO COMPARATOR

One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks

Drug: Vehicle

Interventions

Apraclonidine Hydrochloride Ophthalmic Solution DRUG

Investigational ophthalmic solution applied topically to the eye with a dropper bottle

Also known as: FID 123320

Apraclonidine Hydrochloride Ophthalmic Solution

Vehicle DRUG

Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle

Vehicle

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;
• Willing and able to follow all instructions and attend all study visits;
• Able to self-administer eye drops- in the opinion of the investigator;
• History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
• Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
• Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
• Ocular redness at baseline as specified in the protocol;

You may not qualify if:

• Known contraindications or sensitivities to the use of any of the investigational drug(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 (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
• Disallowed medications or devices as specified in the protocol;
• Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Global Research Management

Glendale, California, 91204, United States

Location

Oculus Research, Inc.

Garner, North Carolina, 27529, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Emerson Clinical Research Institute, Inc.

Falls Church, Virginia, 22046, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Study Officials

• Principal Clinical Trial Lead, Pharma

  Alcon Research, LLC

  STUDY DIRECTOR

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: May 31, 2024
• First Posted: June 5, 2024
• Study Start: August 21, 2024
• Primary Completion: November 14, 2024
• Study Completion: January 8, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)