Reproxalap for Dry Eye Syndrome
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?
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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 0.25% Reproxalap Ophthalmic Solution or vehicle for dry eye disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aldeyra Therapeutics, Inc.
Lead Sponsor
Citations
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-0Press Release Details
In a Dry Eye Chamber Trial, Reproxalap Was Statistically Superior (P=0.002) to Vehicle in Primary Endpoint of Ocular Discomfort.
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, ...
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-0Press 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 ...
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 ...
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 ...
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