ClinicalTrials.gg
RecruitingNCT07629557Updated Jun 5, 2026

Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus

A Phase 4 interventional study of Riboflavin Ophthalmic Solutions and UV-A Irradiation System in Keratoconus, sponsored by Glaukos Corporation. Recruiting at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Glaukos Corporation · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
13 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 94 studies in Keratoconus with a site in United States — 27 open to participants now, 34 under way, 9 of them phase 3. Keratoconus · United States.

Planned enrollment
56th of 71
15 · median 147
Started
2026
with 4 others
Phase 4
4 of 94
2 open now
Primary completion
2027-09
later than 19 of 33 live
Registered
90th of 94
by date
Lead sponsor
8 of 94
Glaukos Corporation

Among the 94 studies in Keratoconus with a site in United States, this one is the 56th largest by planned enrollment of the 71 interventional ones, is one of 5 that started in 2026, is one of 4 in phase 4, reaches primary completion later than 19 of the 33 other live ones, and was the 90th registered.

By phase

94 studies; the count open now beside each. This study's row is marked.

Phase 323 · 5 open
Observational22 · 10 open
No phase17 · 3 open
Phase 212 · 3 open
Phase 2/36 · 1 open
Phase 15 · 1 open
Phase 1/24 · 2 open
Phase 4this study4 · 2 open
Other kind1 · 0 open

By the year they started

First in 1995; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 147 across the 71 interventional studies, 168 across the 21 observational. Of the 42 that completed or were terminated, 15 (36%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 94 studies in Keratoconus with a site in United States, or all of them as a file.
02

Study summary

Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.

03

Conditions studied

  • Keratoconus

Browse trials for

Keywords

  • Keratoconus
  • Corneal Cross-linking
04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 drug or device trial within 30 days of the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Epioxa™ HD/Epioxa™ and UV-A Irradiation

    Epioxa™ HD/Epioxa™ and UV-A Irradiation using the O2n™ System and Supplemental Oxygen using the Boost Goggles®

    Drug: Riboflavin Ophthalmic Solutions · Device: UV-A Irradiation System

Interventions

  • DrugRiboflavin Ophthalmic Solutions

    Riboflavin Ophthalmic Solutions

  • DeviceUV-A Irradiation System

    O2n UV-A Irradiation System

06

What researchers measure

Primary outcomes

  1. Successful completion of bilateral epithelium-on corneal collagen cross-linking.

    Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day.

    Time frame: Approximately 2.5 Months

07

Study locations

1 of 1 sites recruiting
  • Glaukos Investigative Site
    Westerville, Ohio 43082, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Sep 2027, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2026
First posted
Jun 5, 2026
StartActual
May 11, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07629557
Responsible party
Sponsor
First posted
Jun 5, 2026
Start date
May 11, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jun 5, 2026

Study contacts

Study Director
Contact
ClinicalResearch@glaukos.com
949-739-8749
Study Director
study director · Glaukos Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion