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Anti-inflammatory

Reproxalap for Dry Eye Syndrome

Phase 3
Recruiting
Research Sponsored by Aldeyra Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Be older than 18 years old
Must not have
Ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day -14 to day 43
Awards & highlights
Pivotal Trial

Summary

This trial will test the effectiveness and safety of 0.25% Reproxalap in comparison to a control group in treating a certain condition.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from Reproxalap could include temporary eye irritation or discomfort, redness, blurred vision, or an allergic reaction. The placebo might also cause similar sensations due to its application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have an eye infection or inflammation right now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day -14 to day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day -14 to day 43 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subject-reported ocular discomfort score over Week 1 to Week 6

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Reproxalap Ophthalmic Solution (0.25%)Experimental Treatment1 Intervention
Group II: Vehicle Ophthalmic SolutionPlacebo Group1 Intervention

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Who is running the clinical trial?

Aldeyra Therapeutics, Inc.Lead Sponsor
32 Previous Clinical Trials
4,270 Total Patients Enrolled
~100 spots leftby Dec 2024
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