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New eye drops for dry eye pass safety check in large trial

NCT ID NCT04735393

Symptom relief Sponsor: Aldeyra Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the safety of reproxalap eye drops in 757 adults with dry eye disease. Participants used the drops for up to one year. The main goal was to check for serious side effects like vision changes or eye pressure increases. Results will show whether the drops are safe enough to move forward.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
reproxalap ophthalmic solution (0.25%)
What this could lead to
If it works, this could offer a new eye drop option to ease dry eye symptoms with a good safety profile.
What could go wrong
This is a safety-focused trial, not designed to prove the drops work. Even if safe, reproxalap may not relieve symptoms better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

757 people

The number who actually took part.

Started

Jan 2021

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years of age (either gender and any race); * 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. Exclusion Criteria: * Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; * Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial; * Eye drop use within 2 hours of Visit 1; * Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; * Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1; * Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1; * Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye disease

Contacts and locations

Locations

  • Andover Eye Associates

    Andover, Massachusetts, 01810, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.