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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
Be older than 18 years old
Must not have
Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -14 to day 2
Awards & highlights
Pivotal Trial

Summary

This trial will test the effectiveness and safety of a new eye drops solution for treating dry eye disease compared to a control solution.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions associated with eye drops such as temporary discomfort, redness, blurred vision, or an allergic reaction.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I use eye drops or gels that I'm not willing to stop during the trial.
Select...
I currently have an eye infection or inflammation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -14 to day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -14 to day 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 1 and Visit 3

Side effects data

From 2021 Phase 2 trial • 158 Patients • NCT04971031
4%
General disorders and administration site conditions
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vehicle
Reproxalap (0.25%)

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%) administered six times over two consecutive daysExperimental Treatment1 Intervention
Group II: Vehicle Ophthalmic Solution administered six times over two consecutive daysPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reproxalap Ophthalmic Solution (0.25%)
2022
Completed Phase 3
~2820

Find a Location

Who is running the clinical trial?

Aldeyra Therapeutics, Inc.Lead Sponsor
33 Previous Clinical Trials
4,568 Total Patients Enrolled
~18 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
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