Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 13 and up

Same-day bilateral corneal cross-linking for keratoconus

Official title: Single-arm, Multi-center Study to Evaluate the Safety and Feasibility of Bilateral Epithelium-on Corneal Collagen Cross-linking With Epioxa™ HD/Epioxa™ and UV-A Irradiation Using the O2n™ System and Supplemental Oxygen Using the Boost Goggles® in Subjects With Keratoconus

Run by Glaukos Corporation · NCT07629557 · Data updated 2026-11-12

This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.

Quick facts

PhasePhase 4
Study typeInterventional
Ages13 Years and up
SexAll
Enrollment15 (estimated)
SponsorGlaukos Corporation
Industry-sponsored
Locations1 site (Westerville, Ohio)
StatusRecruiting
StartedMay 11, 2026
Main results expectedSeptember 2027
Study endsSeptember 2027
Registry record updatedJune 5, 2026
Trial IDNCT07629557 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with keratoconus in both eyes who can provide informed consent and comply with follow-up.

Probably not a fit

Patients with contraindications to riboflavin or UV-A, prior corneal cross-linking in either eye, or who are pregnant or planning pregnancy may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 study evaluates the safety and practicality of applying riboflavin and UV-A light to both eyes during a single visit in patients with keratoconus. Participants will receive riboflavin ophthalmic solution and UV-A irradiation in both eyes on the same day and will be monitored through follow-up visits to assess adverse events and treatment feasibility. Eligible participants must have keratoconus in both eyes and agree to comply with study instructions. Exclusion criteria include known allergies to study meds, history of corneal disease, prior cross-linking in either eye, pregnancy, or recent participation in other investigational trials.

Why it matters

Potential benefit: If successful, this approach could simplify treatment logistics and potentially reduce overall recovery time for patients.

How similar studies have gone: Previous corneal cross-linking studies support safety and feasibility for single-eye procedures; this exact same-day bilateral approach is less established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Provide written informed consent
* Willing and able to comply with study instructions and follow-up visits
* Diagnosis of keratoconus in each eye

Exclusion Criteria:

* Known allergy or sensitivity to study medications
* History of corneal disease
* Prior corneal cross-linking in either eye
* Pregnant, nursing, or planning pregnancy during the study period
* Participated in other investigational drug or device trial within 30 days of the study

Where it's running

  • Glaukos Investigative Site
    Westerville, Ohio, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.