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New eye drop shows promise for rare corneal disease

NCT ID NCT04485546

Disease control Sponsor: Dompé Farmaceutici S.p.A 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an eye drop called OXERVATE in 37 adults with stage 1 neurotrophic keratitis, a condition where the cornea loses feeling and doesn't heal properly. The treatment was given for 8 weeks, and patients were followed for 24 weeks to see if the cornea healed safely. The main goal was to check how many patients had complete corneal healing.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

37 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 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: 1. Male or female aged ≥ 18 years. 2. Patients with Stage 1 NK defined by the Mackie criteria Exclusion Criteria: 1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye. 2. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome. 3. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease. 4. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind. 5. Ocular surgery or elective ocular surgery expected during participation in the trial. 6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.

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Conditions

The condition(s) this trial relates to.

corneal disorder neurotrophic keratopathy

As listed by the trial registrant

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

Neurotrophic keratitis

Contacts and locations

Locations

  • Boston

    Boston, Massachusetts, 02111, United States

  • Edgewood

    Edgewood, Kentucky, 41017, United States

  • Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Saint Louis

    St Louis, Missouri, 63131, United States

  • San Diego

    San Diego, California, 92122, United States

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