Apraclonidine for Eye Redness

AC
Overseen ByAlcon Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alcon Research
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an eye drop called Apraclonidine Ophthalmic Solution to evaluate its effectiveness in reducing eye redness from minor irritations. Researchers aim to determine its safety and efficacy compared to a placebo (an inactive substance). Suitable candidates for this trial are adults who have used or are interested in using redness relief eye drops and have noticeable eye redness. Participants will receive a single dose in each eye to help assess if this treatment can provide relief. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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

The trial information does not clearly state 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 specific 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, the main ingredient in the eye drops being tested, is generally safe. Earlier studies with apraclonidine 0.5% eye drops found no harmful effects in animal tests, even at higher doses. However, some individuals might experience mild side effects such as eye redness, itching, or discomfort. These effects resemble allergic reactions but are usually manageable.

Rare reports exist of more serious reactions, mostly in infants or young children. For adults, the drops might increase sensitivity to light, so wearing sunglasses could help. Overall, the treatment is well-tolerated by adults and has been used for other eye conditions, indicating it is likely safe for its intended use.12345

Why do researchers think this study treatment might be promising for eye redness?

Unlike the standard treatments for eye redness, which often include over-the-counter drops or antihistamines, Apraclonidine Ophthalmic Solution offers a new approach by using a selective alpha-2 adrenergic agonist. This mechanism works by constricting blood vessels in the eye, which can reduce redness more effectively and quickly. Researchers are excited about this treatment because it is preservative-free and administered as a single-dose drop, potentially reducing irritation and making it a convenient option for patients seeking rapid relief from eye redness.

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

Studies have shown that Apraclonidine Hydrochloride Eye Drops effectively reduce eye redness from minor irritations. In this trial, participants will receive either Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free, or a placebo vehicle. Research indicates that Apraclonidine narrows the blood vessels in the eye, which helps decrease redness. Apraclonidine also lowers eye pressure in other conditions, demonstrating its ability to influence blood flow in the eye. Overall, these findings suggest that Apraclonidine holds promise for reducing eye redness.26789

Who Is on the Research Team?

CT

Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for adults with noticeable eye redness from minor irritation, who have healthy eyes and good vision. Participants should be interested in or have used redness relief drops recently. People who've had recent eye surgery, are pregnant or breastfeeding, or have certain eye conditions can't join.

Inclusion Criteria

My eye health is stable.
Best corrected visual acuity at distance of 0.3 logarithm Minimum Angle of Resolution or better in each eye
Other protocol-defined inclusion criteria may apply
See 4 more

Exclusion Criteria

I have had eye surgery in the past 6 months or plan to have it during the study.
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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive a single dose of the study treatment in each eye on Day 1

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

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 apraclonidine ophthalmic solution (0.125% preservative-free) to a placebo (vehicle) to see how well it reduces eye redness in adults. Treatments are given as eyedrops.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative FreeExperimental Treatment1 Intervention
Group II: VehiclePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials
739
Recruited
128,000+
Raquel C. Bono profile image

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott profile image

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Citations

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 ...

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 ...

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) ...

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) ...

An Evaluation of the Efficacy and Safety of FID 123472 ...

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

SDS: Apraclonidine Ophthalmic Solution, USP 0.5%

Supplementary Information: May cause eye, skin, and respiratory irritation. Systemically absorbed via eyes, skin, and ingestion. 3. Composition/Information on ...

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

This report recommended using caution with apraclonidine eye drops in infants or avoiding their use especially in those under the age of 6 months. Apraclonidine ...

Apraclonidine (ophthalmic route) - Side effects & dosage

Apraclonidine 0.5% eye drops is used to treat glaucoma when the medications you have been using for glaucoma do not reduce your eye pressure enough.

Systemic Side Effects May Occur After Use ...

Apraclonidine ophthalmic drops may cause rare but serious systemic adverse events (AEs) when given to infants and children.