Reproxalap for Dry Eye Syndrome

Overseen By Annalisa Webb

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Aldeyra Therapeutics, Inc.

Must not be taking: Cyclosporine, Lifitegrast, Corticosteroids, others

Disqualifiers: 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: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop treatment called Reproxalap for individuals with Dry Eye Syndrome. Researchers aim to determine if these drops can relieve symptoms such as redness, irritation, or the sensation of sand in the eyes. Participants will receive either the Reproxalap drops or a placebo (a solution with no active medicine). Candidates may be suitable if they currently use or wish to use eye drops for dry eyes and have not had recent eye surgeries or infections. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

If you are using any prescription eye drops, you will need to stop them at least 90 days before starting the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research has shown that Reproxalap has been tested in over 2,900 people. The studies found no major safety issues. Some participants experienced mild and short-lived eye irritation, the most common issue. No serious safety problems emerged, suggesting that Reproxalap is generally safe for use. ^{1 2 3 4 5}

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

Reproxalap is unique because it targets dry eye syndrome in a novel way by inhibiting reactive aldehyde species (RASP). Most current treatments focus on lubricating the eyes or reducing inflammation, like artificial tears and anti-inflammatory drops. Reproxalap, on the other hand, works by reducing oxidative stress, which is believed to be a root cause of the irritation and inflammation seen in dry eye syndrome. Researchers are excited because this new mechanism of action could offer faster relief and potentially long-lasting effects compared to standard treatments.

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

Studies have shown that Reproxalap significantly reduces discomfort in people with dry eye syndrome. In this trial, participants will receive either the Reproxalap Ophthalmic Solution (0.25%) or a Vehicle Ophthalmic Solution as a placebo comparator. Previous research indicates that Reproxalap outperformed a placebo in easing eye discomfort, with strong evidence supporting this (P=0.002). It also helped reduce eye redness and increased tear production, common issues in dry eye disease. However, some trials showed mixed results, such as not achieving certain goals for reducing redness. Despite this, the overall evidence suggests that Reproxalap offers promising relief for dry eye symptoms. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Dry Eye Disease, a condition where eyes do not stay properly lubricated. Participants should have a confirmed diagnosis and may need to meet other specific health criteria set by the study.

Inclusion Criteria

I have signed the consent and HIPAA forms.

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

Exclusion Criteria

Use of contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial

Use of eye drops within 2 hours of Visit 1

I do not have an eye infection or inflammation right now.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive 0.25% Reproxalap Ophthalmic Solution or vehicle for dry eye disease

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Reproxalap

Trial Overview The trial is testing the effectiveness of Reproxalap ophthalmic solution (0.25%) compared to a vehicle (placebo) solution in improving symptoms of dry eye. It's conducted at multiple centers, with participants randomly assigned to either treatment.

How Is the Trial Designed?

Group I: Reproxalap Ophthalmic Solution (0.25%) Experimental Treatment 1 Intervention

Group II: Vehicle Ophthalmic Solution 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 ... All endpoints were assessed over approximately a 24-hour period of dosing, suggesting rapid activity of reproxalap. • The crossover trial design ...

2. 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.

3. 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 ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/fda-rejects-aldeyras-dry-eye-drug-asks-for-more-clinical-data/

FDA rejects Aldeyra's dry eye drug, asks for more clinical ... The drug failed to meet its primary endpoint of reduction in conjunctival redness in the Phase III TRANQUILITY trial (NCT04674358). However, ...

5. 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 trial is for individuals with Dry Eye Disease, a condition where eyes do not stay properly lubricated. Participants should have a confirmed diagnosis and ...

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

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11334916/

Tolerability of Current Treatments for Dry Eye Disease An open-label phase 4 study found similar safety events, with the most commonly reported ocular AEs including instillation-site burn (3/40 [7.5 ...

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

ADX-102-DED-009 Reproxalap Ophthalmic Solutions (0.25% and 0.1%) vs vehicle for the treatment of the signs and symptoms of dry eye disease to confirm the ...