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

June 1, 2026 updated by: Glaukos Corporation

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Riboflavin Ophthalmic Solutions
Device: UV-A Irradiation System
O2n UV-A Irradiation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful completion of bilateral epithelium-on corneal collagen cross-linking.
Time Frame: Approximately 2.5 Months
Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day.
Approximately 2.5 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaukos Corporation

Investigators

  • Study Director: Study Director, Glaukos Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLK-202-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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