New eye drops aim to quickly soothe dry eye pain
NCT ID NCT06493604
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 3 trial tested whether 0.25% reproxalap eye drops can reduce discomfort from dry eye disease better than a placebo. 116 adults with dry eye for at least 6 months used the drops six times over two days. The main goal was to measure changes in eye discomfort using a pain scale.
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 provide a new eye drop option to quickly ease discomfort from dry eye disease.
- What could go wrong
- This is a small, short-term trial (116 people, 2 days of treatment). Results may not apply to long-term use or all patients. Side effects are possible.
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
-
116 people
The number who actually took part.
- Started
-
Jun 2024
- Finished
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Feb 2025
- 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
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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 Hide 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) * Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form * Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1 * Reported 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, 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 anticipated use of contact lenses during the trial * Previous laser-assisted in situ keratomileusis surgery within the last 12 months * Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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.
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- Can a new eyedrop heal the cornea in dry eye disease?
- Can a daily eye drop safely treat dry eye? phase 3 trial puts tivanisiran to the test
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- Can a new eye drop fully clear dry eye redness?
- Could a common dry eye drop shield the Cornea's inner layer?