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

A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

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.

Study Overview

• Status: Completed
• Conditions: Ocular Redness
• Intervention / Treatment: Drug: Apraclonidine Hydrochloride Ophthalmic Solution; Drug: Vehicle

Detailed Description

The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91204
      • Global Research Management
  • North Carolina
    • Garner, North Carolina, United States, 27529
      • Oculus Research, Inc.
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute, Inc.
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• 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;
• 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 HCl 0.125%; 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).	Drug: Apraclonidine Hydrochloride Ophthalmic Solution; Investigational ophthalmic solution applied topically to the eye with a dropper bottle; Other Names: Apraclonidine HCl 0.125%
Placebo Comparator: Vehicle; 1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).	Drug: Vehicle; Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 15 Minutes Post-instillation on Day 1	Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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). The change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Minute 15 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 10 Hours (600 Minutes) Post-instillation on Day 1	Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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). The change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 10 (600 minutes) (Day 1 post-instillation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 1 Minute Post-instillation on Day 1	Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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). The change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Minute 1 (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-assessed Ocular Redness at 8 Hours (480 Minutes) Post-instillation on Day 1	Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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). The change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 8 (480 minutes) (Day 1 post-instillation)
Least Squares Mean Change From Baseline in Investigator-Assessed Ocular Redness at 12 Hours (720 Minutes) Post-instillation on Day 1	Ocular redness was assessed by the investigator using the Ora Calibra® Ocular Hyperemia Scale, which ranged 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). The change from baseline, calculated as post-instillation minus baseline scores, 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 pre-instillation); Hour 12 (720 minutes) (Day 1 post-instillation)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• <p>Educational</p>

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): November 14, 2024
• Study Completion (Actual): January 8, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 10, 2026
• Last Update Submitted That Met QC Criteria: October 16, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Eye redness; Irritated eyes
• Other Study ID Numbers: DEW422-C001

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