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Promising new eye treatment could halt vision loss from keratoconus

NCT ID NCT06100952

Disease control Sponsor: Epion Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested a new type of corneal cross-linking that does not require removing the surface layer of the eye. It involved 398 people aged 8 to 45 with keratoconus, a condition that thins and bulges the cornea. The treatment uses riboflavin eye drops and ultraviolet light to strengthen the cornea and stop the disease from progressing.

What this could mean

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

Active substance
Riboflavin and sodium iodide eye drops plus ultraviolet-A light treatment
What this could lead to
If successful, this could offer a less painful, faster-recovery treatment to stop keratoconus from getting worse and improve vision.
What could go wrong
This is a phase 3 trial, but results are not yet published. The treatment may not work better than a sham procedure, and there are risks like infection or corneal scarring.

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

398 people

The number who actually took part.

Started

Nov 2023

Finished

Mar 2026

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

8 to 45 years

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: * Diagnosis of keratoconus Exclusion Criteria: * Minimal corneal thickness \< 350 microns * Non-keratoconic ectatic disease * Contraindications or hypersensitivities to any required study medications * Pregnancy or breastfeeding * Certain concomitant ocular conditions

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Conditions

The condition(s) this trial relates to.

keratoconus

As listed by the trial registrant

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

Keratoconus

Contacts and locations

Locations

  • Catalina Eye Center

    Tucson, Arizona, 85712, United States

  • Chicago Cornea Consultants

    Highland Park, Illinois, 60035, United States

  • Claris Vision LLC Eye Health Vision Centers - Dartmouth

    North Dartmouth, Massachusetts, 02747, United States

  • Dell Laser Consultants

    Austin, Texas, 78746, United States

  • Hoopes Vision

    Draper, Utah, 84020, United States

  • Inland Eye Specialists

    Murrieta, California, 92562, United States

  • Providence Eye and Laser Specialists

    Charlotte, North Carolina, 28226, United States

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260, United States

  • Truhlsen Eye Institute

    Omaha, Nebraska, 68105, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • VRF Eye Specialty Group

    Memphis, Tennessee, 38120, United States

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502, United States

More trials for these conditions

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