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Completed

NCT Number: NCT06444529

A Double-Masked Comparison of FID 123320 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.

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Key information

Conditions

Ocular Redness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Research Management, Glendale, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apraclonidine Hydrochloride Ophthalmic Solution

Drug

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

Other names: FID 123320

Vehicle

Drug

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

Primary outcomes

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

    Time frame: Day 1: Pretreatment; 15 minutes post-treatment

    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.

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

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

    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.

Secondary outcomes

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

    Time frame: Day 1: Pretreatment; 1 minute post-treatment

    Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).

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

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

    Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).

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

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

    Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 5, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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