Apraclonidine Eye Drops for Red Eye

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of Apraclonidine eye drops (Apraclonidine Hydrochloride Ophthalmic Solution) in reducing redness from minor eye irritations. Participants will use either the Apraclonidine drops or a placebo (a treatment with no active drug) for about eight weeks. The study seeks individuals who have used redness relief eye drops in the past six months or wish to start using them. As a Phase 3 trial, it represents the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that certain medications might be disallowed, so it's best to discuss your current medications with the study team.

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

Research shows that apraclonidine hydrochloride eye drops are usually well-tolerated. In past studies, 5% to 15% of patients reported mild side effects such as eye discomfort, redness, and itching. These effects were not serious and are common with many eye drops.

The eye drops are also safe for the rest of the body, as they don't cause harmful effects elsewhere. Occasionally, some people might experience a local allergic reaction or temporary redness, but this is rare. Overall, these findings suggest that apraclonidine hydrochloride is safe for use, with side effects mostly being minor and related to the eyes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about apraclonidine hydrochloride eye drops for red eye because they offer a novel approach compared to traditional treatments like artificial tears, vasoconstrictors, and antihistamines. Unlike these standard treatments, which primarily address symptoms, apraclonidine hydrochloride works by reducing blood flow to the eye's blood vessels, effectively decreasing redness. This targeted mechanism not only offers a new way to manage red eye but also has the potential for more rapid and sustained relief.

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

Studies have shown that Apraclonidine Hydrochloride Eye Drops effectively reduce eye redness from minor irritations. Research indicates that this treatment significantly lowers intraocular pressure, helping to reduce redness. Previous findings with apraclonidine demonstrate its success in managing symptoms in conditions like glaucoma, where reducing eye pressure is crucial. These results suggest that apraclonidine may effectively address eye redness by decreasing pressure and irritation. Participants in this trial will receive either Apraclonidine Hydrochloride Ophthalmic Solution or a placebo comparator to evaluate its effectiveness in treating red eye. ^{1 6 7 8 9}

Who Is on the Research Team?

Principal Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06444529

Study Details | NCT06444529 | A Double-Masked ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7573299/

Short-term efficacy of apraclonidine hydrochloride added to ... Apraclonidine treatment resulted in significantly more patients attaining an additional 20% reduction or more in intraocular pressure from baseline and an ...

3. mayoclinic.org mayoclinic.org/drugs-supplements/apraclonidine-ophthalmic-route/description/drg-20062024

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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8590259/

Evaluation of adverse reactions of aponidine hydrochloride ... The ocular hypotensive effects were statistically significant for apraclonidine-treated eyes throughout the study and also statistically significant for ...

5. go.drugbank.com go.drugbank.com/indications/DBCOND0023338/clinical_trials/DB00964?phase=3&status=completed

Eye redness Completed Phase 3 Trials for Apraclonidine ... NCT06444529. A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness, Treatment.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/020258s026lbl.pdf

IOPIDINE® 0.5% (apraclonidine ophthalmic solution) 0.5% Ocular The following adverse reactions were reported in 5 to 15% of the patients: discomfort, hyperemia, and pruritus.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8719690/

Topical apraclonidine hydrochloride in eyes with poorly ... Conclusions: Apraclonidine appears safe and efficacious. It significantly lowered IOP when used in combination with a patient's maximum tolerated medical ...

8. drugs.com drugs.com/sfx/apraclonidine-ophthalmic-side-effects.html

Apraclonidine Ophthalmic Side Effects General adverse events: The most commonly reported side effects were hyperemia, pruritus, discomfort, and tearing.

9. aao.org aao.org/eye-health/diseases/glaucoma-medications

Glaucoma: Medications Apraclonidine is systemically safe; effect can wear off; rarely, local allergy or red eye. Brimonidine can cause bradycardia, hypotension ...