Apraclonidine Eye Drops for Red Eye

Recruiting at 5 trial locations

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alcon Research

Disqualifiers: Ocular surgery, Ocular conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

159 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Principal Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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.

Inclusion Criteria

Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study

My eyesight, with correction, is at least 20/40 in both eyes.

I can sign and understand the consent form.

Exclusion Criteria

I am not allergic or sensitive to the drugs used in this study or any required medication.

Disallowed medications or devices as specified in the protocol

Other protocol-defined exclusion criteria may apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Apraclonidine Hydrochloride Ophthalmic Solution or Vehicle for approximately 8 weeks

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Apraclonidine Hydrochloride Ophthalmic Solution

Trial Overview 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.

Participant Groups

Group I: Apraclonidine Hydrochloride Ophthalmic Solution Experimental Treatment 1 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: Vehicle Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California