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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-01-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Ocular Redness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apraclonidine Hydrochloride Ophthalmic Solution

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

Group Type EXPERIMENTAL

Apraclonidine Hydrochloride Ophthalmic Solution

Intervention Type DRUG

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

Vehicle

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

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

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

Interventions

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Apraclonidine Hydrochloride Ophthalmic Solution

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

Intervention Type DRUG

Vehicle

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

Intervention Type DRUG

Other Intervention Names

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FID 123320

Eligibility Criteria

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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;

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No