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Alpha-2 Adrenergic Agonist

Apraclonidine Eye Drops for Red Eye

Phase 3
Recruiting
Research Sponsored by Alcon Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: pretreatment; 12 hours (720 minutes) post-treatment
Awards & highlights
Pivotal Trial

Summary

This trial aims to test whether Apraclonidine eye drops are safe and effective in reducing redness in the eyes caused by minor irritations, compared to a placebo. The study will take place in

Who is the study for?
This trial is for individuals experiencing redness of the eye due to minor irritations. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study.
What is being tested?
The trial is testing Apraclonidine Hydrochloride Ophthalmic Solution 0.125% against a placebo (Vehicle) to see if it's more effective in reducing eye redness. It's a double-masked study, meaning neither participants nor researchers know who receives which treatment.
What are the potential side effects?
While specific side effects are not listed here, ophthalmic solutions like Apraclonidine can sometimes cause local irritation, dry eyes, or allergic reactions. Systemic side effects are less common but may include dizziness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used eye drops for redness or want to use them.
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My eyesight, with correction, is at least 20/40 in both eyes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic or sensitive to the drugs used in this study or any required medication.
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I have not had eye surgery in the last 6 months nor will I during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pretreatment; 12 hours (720 minutes) post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: pretreatment; 12 hours (720 minutes) post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1
Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1
Secondary study objectives
Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1
Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1
Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Apraclonidine Hydrochloride Ophthalmic SolutionExperimental Treatment1 Intervention
One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks
Group II: VehiclePlacebo Group1 Intervention
One drop in each eye on Day 1, followed by 2 drops in each eye on Day 2 onward for approximately 8 weeks

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Who is running the clinical trial?

Alcon ResearchLead Sponsor
731 Previous Clinical Trials
128,669 Total Patients Enrolled
Principal Clinical Trial Lead, PharmaStudy DirectorAlcon Research, LLC
~0 spots leftby Dec 2024
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