Reproxalap for Dry Eye Syndrome

Overseen By Bill Cavanagh

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Aldeyra Therapeutics, Inc.

Must not be taking: Systemic corticosteroids, Immunomodulators

Disqualifiers: Blepharitis, Ocular infection, Contact lenses, 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: 2

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop medicine, Reproxalap Ophthalmic Solution, for individuals with dry eye disease. The goal is to evaluate Reproxalap's effectiveness compared to a placebo (a solution with no active ingredient) and ensure its safety. Participants will apply the eye drops six times over two days. This trial suits those who have experienced eye discomfort and have used or considered using eye drops for dry eyes in the past six months. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

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

Yes, you will need to stop using any topical eye medications, except for artificial tears, for the duration of the trial. If you are on systemic corticosteroids or other immunomodulators, you must stop them at least 14 days before starting the trial.

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

Research has shown that Reproxalap Eye Drops have been tested on over 2,900 people. These studies found no safety problems. Some participants experienced mild and temporary irritation at the application site, but this was the only reported issue. This indicates that Reproxalap is generally well-tolerated by most people. ^{1 2 3 4 5}

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

Unlike the standard treatments for dry eye syndrome, which often include artificial tears and anti-inflammatory medications, Reproxalap is unique because it targets the underlying inflammation through a novel mechanism. Reproxalap uses an aldehyde-trapping agent that reduces the inflammatory response in the eye, potentially offering quicker relief from symptoms. Researchers are excited about Reproxalap because it has shown promise in delivering noticeable results in just a couple of days, which is faster than many existing options. This rapid action could significantly improve comfort and quality of life for people suffering from dry eye syndrome.

What evidence suggests that Reproxalap might be an effective treatment for Dry Eye Disease?

Studies have shown that reproxalap eye drops effectively treat dry eye disease. In trials, they improved symptoms such as eye redness, discomfort, and tear production compared to a placebo. Participants in this trial will receive either the Reproxalap Ophthalmic Solution or a Vehicle Ophthalmic Solution as a placebo comparator. One study found that reproxalap significantly reduced eye discomfort, a primary concern for people with dry eyes. Researchers have studied over 1,800 patients, and no major safety issues have been reported. This evidence suggests that reproxalap could be a promising option for managing dry eye symptoms. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Dry Eye Disease, a condition where eyes don't produce enough tears or the right quality of tears. Participants should have a confirmed diagnosis and meet other study requirements not specified here.

Inclusion Criteria

Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form

I have used or wanted to use eye drops for dry eyes in the last 6 months.

I have had dry eye discomfort for at least 6 months.

Exclusion Criteria

I had LASIK eye surgery less than a year ago.

Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters

I haven't taken systemic steroids or immune therapies in the last 14 days and don't plan to during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either Reproxalap Ophthalmic Solution or Vehicle Ophthalmic Solution six times over two consecutive days

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reproxalap Ophthalmic Solution

Trial Overview

The trial is testing the effectiveness and safety of Reproxalap Ophthalmic Solution (0.25%) compared to a placebo solution in people with Dry Eye Disease. It's set up so neither participants nor researchers know who gets the real treatment versus placebo.

How Is the Trial Designed?

Group I: Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days Experimental Treatment 1 Intervention

Group II: Vehicle Ophthalmic Solution administered six times over two consecutive days Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Aldeyra Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

4,700+

Citations

1.

ir.aldeyra.com

ir.aldeyra.com/static-files/e27def1e-2c05-49ce-baa4-9bc67ef03444

Top-Line Results from the Dry Eye Disease Chamber ...

Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 1,800 patients with no observed safety ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12553042/

Reproxalap Improves Ocular Redness, Tear Production, and ...

The results of the clinical trial demonstrated that reproxalap was more effective than vehicle in acutely ameliorating the signs and symptoms of dry eye disease ...

3.

empr.com

empr.com/news/reproxalap-improves-ocular-discomfort-in-second-dry-eye-chamber-trial/

Reproxalap Improves Ocular Discomfort in Second Dry Eye ...

Reproxalap ophthalmic solution 0.25% reached the primary endpoint in a second phase 3 dry eye chamber trial, according to Aldeyra Therapeutics.

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/15/NCT03404115/Prot_000.pdf

ADX-102-DED-009

Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with. Dry Eye Disease. Protocol Number: ADX-102 ...

5.

ir.aldeyra.com

ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-achieves-primary-endpoint-phase-3-dry-eye-0

Press Release Details

In a Dry Eye Chamber Trial, Reproxalap Was Statistically Superior (P=0.002) to Vehicle in Primary Endpoint of Ocular Discomfort.

6.

ir.aldeyra.com

ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-fda-acceptance-review-0

Aldeyra Therapeutics Announces FDA Acceptance for Review ...

Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the ...

7.

withpower.com

withpower.com/trial/phase-3-keratoconjunctivitis-sicca-3-2024-eadcc?condition=&query=Keratoconus&overallStatus=Recruiting&hasNoPlacebo=false

Reproxalap for Dry Eye Syndrome · Info for Participants

This Phase 3 medical study run by Aldeyra Therapeutics, Inc. needs participants to evaluate whether Reproxalap will have tolerable side effects & efficacy ...