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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 13 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Westerville, Ohio) |
| Status | Recruiting |
| Started | May 11, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07629557 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
- Study coordinator: Study Director
- Email: ClinicalResearch@glaukos.com
- Phone: 949-739-8749
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia
This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.
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GLK-221 eye drops for keratoconus
This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.
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Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus
This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.
-
Epi-ON corneal crosslinking with UVA for people with Down syndrome and corneal ectasia
This trial will try Epi-ON corneal crosslinking (riboflavin drops plus UVA light) to see if it can slow or stop corneal thinning and vision loss in people with Down syndrome who have keratoconus or similar ectatic corneal conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.