Apraclonidine for Eye Redness

Overseen By Alcon Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alcon Research

Disqualifiers: Ocular surgery, Pregnancy, Breastfeeding, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop called Apraclonidine to determine its safety and effectiveness in reducing redness caused by minor eye irritations. Participants will receive either the Apraclonidine solution or a placebo (a substance with no active medicine) for comparison. Individuals who have used redness relief eye drops in the last six months, or those interested in trying them, might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that the use of certain prohibited medications, devices, or treatments is not allowed, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that Apraclonidine Ophthalmic Solution is likely to be safe for humans?

Research has shown that apraclonidine eye drops are generally safe for reducing eye redness from minor irritations. In past studies, serious reactions to these eye drops were rare, even in children and infants. However, some rare but serious side effects affecting the whole body have occurred in younger patients. Adults tolerate the treatment well, with no major issues related to the drug observed in trials. Apraclonidine is already approved for other eye-related uses, which adds confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for eye redness, which typically include over-the-counter decongestant eye drops that temporarily constrict blood vessels, Apraclonidine Ophthalmic Solution offers a unique approach. Apraclonidine works by stimulating alpha-adrenergic receptors, which reduces eye redness through a different mechanism. Researchers are excited because this could provide a longer-lasting and more effective solution for managing eye redness compared to traditional options. Additionally, its specific formulation at 0.125% is designed to be both potent and safe for regular use over an extended period.

What evidence suggests that Apraclonidine Ophthalmic Solution might be an effective treatment for ocular redness?

Studies have shown that Apraclonidine Hydrochloride Eye Drops effectively reduce eye redness from minor irritations. This treatment narrows the blood vessels in the eye, decreasing redness. Patients with similar conditions previously reported noticeable improvement in redness after using Apraclonidine. Other research has demonstrated that Apraclonidine can also lower high pressure inside the eye, highlighting its potential usefulness for eye-related issues. These findings suggest Apraclonidine could be a promising option for treating eye redness. Participants in this trial will receive either Apraclonidine 0.125% or a placebo vehicle to evaluate its effectiveness in reducing eye redness. ^{1 3 5 6 7}

Who Is on the Research Team?

Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for adults who have eye redness due to minor irritations. People with other serious eye conditions or allergies to the study medications likely cannot participate.

Inclusion Criteria

I have used or want to use redness relief eyedrops in the past 6 months.

Best corrected visual acuity at distance of 0.3 logarithm Minimum Angle of Resolution or better in each eye

Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form

Exclusion Criteria

Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol

Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters

Other protocol-defined exclusion criteria may apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of study treatment in each eye on Day 1, followed by self-administration of one drop in each eye twice daily at home for approximately 8 weeks

8 weeks

5 visits (in-person)

Follow-up

Participants return for the final study visit after a 1-week treatment discontinuation to assess ocular redness

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Apraclonidine Ophthalmic Solution

Trial Overview

The study compares an investigational eye drop (Apraclonidine Ophthalmic Solution, 0.125%, preservative free) against a placebo (vehicle) to see how well it reduces eye redness in adults.

How Is the Trial Designed?

Group I: Apraclonidine 0.125% UDPF Experimental Treatment 1 Intervention

One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.

Group II: Vehicle Placebo Group 1 Intervention

One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07531043

NCT07531043 | An Evaluation of the Efficacy and Safety ...

The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07578363

An Investigation of FID 123472 Ophthalmic Solution to ...

The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness caused ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/7721118/

Efficacy of apraclonidine ophthalmic solution (Iopidine) in ...

In the POAG group, IOP was reduced from 25.9 +/- 1.9 mmHg before treatment to 18.9 +/- 1.4 mmHg after 1 h (P < 0.001), 17.7 +/- 1.2 mmHg after 2 h (P < 0.001) ...

4.

withpower.com

withpower.com/trial/phase-3-ocular-redness-7-2024-1756e

Apraclonidine Eye Drops for Red Eye · Info for Participants

Studies have shown that Apraclonidine Hydrochloride Eye Drops effectively reduce eye redness from minor irritations. Research indicates that this treatment ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2026/020258s034lbl.pdf

IOPIDINE® (apraclonidine ophthalmic solution) 0.5% as base

When instilled in the eye, IOPIDINE® (apraclonidine ophthalmic solution) 0.5%, has the action of reducing elevated, as well as normal, intraocular pressure (IOP) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8792311/

Safety of apraclonidine eye drops in diagnosis of Horner ...

Based on our results, severe systemic adverse reactions to apraclonidine eye drop testing for anisocoria are rare in children, even in young infants. Some ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1091853121005577

Safety of apraclonidine eye drops in diagnosis of Horner ...

The use of topical apraclonidine eyedrops has been described as an effective test for Horner syndrome. However, concerns have been raised regarding the ...