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: Cyclosporine, Lifitegrast

Disqualifiers: Blepharitis, MGD, Ocular infection, 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 the safety of a new eye drop called Reproxalap for people with dry eye disease. Participants will use either Reproxalap or a placebo (a look-alike treatment with no active ingredients) for varying durations to assess the treatment's effectiveness. The trial seeks individuals who have experienced dry eye symptoms and have used or considered using eye drops in the past six months. As a Phase 3 trial, this study serves as the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use certain eye drops like cyclosporine or lifitegrast within 90 days before starting the trial. You also cannot use any eye drops within 2 hours of your first visit.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Reproxalap Eye Drops are generally safe. Studies have found that individuals with dry eye disease tolerate them well, with no major safety issues identified. Clinical trials revealed no significant changes in key eye health measures, such as vision clarity or overall eye health. Additionally, basic health measures like blood pressure and heart rate remained stable. Overall, Reproxalap has demonstrated positive safety results over time for those with dry eye disease. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Reproxalap Ophthalmic Solution for dry eye disease because it offers a novel approach compared to current treatments like artificial tears and anti-inflammatory drops. Unlike these standard options, Reproxalap works by targeting aldehydes, which are inflammatory molecules that can worsen dry eye symptoms. This mechanism is different and could potentially provide more effective relief. Additionally, Reproxalap is applied directly to the eyes, making it a convenient and targeted treatment option.

What evidence suggests that Reproxalap Ophthalmic Solution could be an effective treatment for dry eye disease?

Research has shown that Reproxalap eye drops effectively treat dry eye disease. Studies indicate that they significantly reduce eye redness, a primary symptom of the condition, and help increase tear production, keeping the eyes moist. Additionally, Reproxalap has been shown to lessen eye itching. In this trial, participants will receive either Reproxalap or a placebo comparator to further evaluate its effectiveness. These findings suggest that Reproxalap can provide relief for people with dry eye symptoms. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

Reported history of dry eye for at least 6 months prior to Visit 1;

History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Reproxalap or vehicle four times daily for four weeks followed by two times daily for two weeks

6 weeks

Extended Treatment

Participants continue receiving Reproxalap or vehicle two times daily for an additional 11 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Comparator
• Reproxalap Ophthalmic Solution

How Is the Trial Designed?

Group I: Reproxalap (0.25%) for six weeks Experimental Treatment 1 Intervention

Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks

Group II: Reproxalap (0.25%) for 12 months Experimental Treatment 1 Intervention

Reproxalap (0.25%) QID for four weeks followed by BID for 11 months

Group III: Vehicle for six weeks Placebo Group 1 Intervention

Vehicle QID for four weeks followed by BID for two weeks

Group IV: Vehicle for 12 months Placebo Group 1 Intervention

Vehicle QID for four weeks followed by BID for 11 months

Who Is Running the Clinical Trial?

Aldeyra Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

4,700+

Published Research Related to This Trial

In a review of 200 randomized drug trials published in 2013, only 1 trial (0.5%) used an active placebo, indicating that these control groups are rarely employed in clinical research.

Active placebos are more commonly found in trials involving drugs with noticeable side effects, as they help reduce the risk of unblinding, although they also carry the risk of causing unintended therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview. Jensen, JS., Bielefeldt, AØ., Hróbjartsson, A.[2018]

In a clinical trial involving 19 patients with dry eye disease, both formulations of reproxalap demonstrated significantly better comfort and fewer side effects compared to lifitegrast, particularly in terms of ocular discomfort, blurry vision, and dysgeusia.

Reproxalap not only resulted in lower rates of negative responses but also had shorter durations of these responses, suggesting it may enhance patient adherence to treatment due to a more favorable overall experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Post-Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25% and Lifitegrast 5% in Patients with Dry Eye Disease. McMullin, D., Clark, D., Cavanagh, B., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525002362

Reproxalap Improves Ocular Redness, Tear Production ... Results. Relative to vehicle, reproxalap treatment statistically significantly diminished ocular redness, and increased Schirmer score and % ≥10 ...

2. ir.aldeyra.com ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-top-line-results-phase-3

Press Release Details Aldeyra's recently completed Phase 2 clinical trial achieved the primary endpoint of ocular redness, an approvable sign of dry eye disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10725700/

The Phase 3 INVIGORATE Trial of Reproxalap in Patients ... Primary and key secondary endpoints were met: reproxalap significantly reduced ocular itching (mean [SE]: −0.50 [0.03], p < 0.001) and redness ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05424549?term=AREA%5BLeadSponsorName%5D(Aldeyra%20Therapeutics,%20Inc.)&rank=8

Study Details | NCT05424549 | A Clinical Trial to Evaluate ... A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease. Sponsor Aldeyra Therapeutics , Inc .

5. 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.

6. ir.aldeyra.com ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-resubmits-reproxalap-new-drug-application-0

Aldeyra Therapeutics Resubmits Reproxalap New Drug ... No notable differences in baseline scores across treatment arms were observed in the clinical trial, and no safety concerns were identified.

7. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00236-2/fulltext

Reproxalap Improves Ocular Redness, Tear Production ... Reproxalap was considered safe and well tolerated. No clinically significant changes in visual acuity readings, fundus assessments, vital signs, or clinical ...

8. ir.aldeyra.com ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-positive-top-line-results-12

Press Release Details Aldeyra Therapeutics Announces Positive Top-Line Results from 12-Month Safety Clinical Trial of Reproxalap in Patients with Dry Eye Disease.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT03916042/Prot_000.pdf

Clinical Trial Protocol: ADX-102-DED-013 The overall objective of this study is to evaluate the safety and efficacy of Reproxalap. Ophthalmic Solution (0.25% Novel Formulation) compared ...