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

NCT07629557 — Phase 4, Recruiting, 15 participants, Glaukos Corporation

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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

Registry	NCT07629557
Status	Recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	15 (Estimated)
Sponsor	Glaukos Corporation (Industry)
Conditions	Keratoconus
Interventions	Riboflavin Ophthalmic Solutions, UV-A Irradiation System (Drug, device)
Dates	start 2026-05-11, primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-06-05, last updated 2026-06-05
Locations	1 site in United States

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
Epioxa™ HD/Epioxa™ and UV-A Irradiation	Experimental	Drug: Riboflavin Ophthalmic Solutions; Device: UV-A Irradiation System	Epioxa™ HD/Epioxa™ and UV-A Irradiation using the O2n™ System and Supplemental Oxygen using the Boost Goggles®

Riboflavin Ophthalmic Solutions (Drug): Riboflavin Ophthalmic Solutions
UV-A Irradiation System (Device): O2n UV-A Irradiation System

+Outcome measures

Primary outcomes

Successful completion of bilateral epithelium-on corneal collagen cross-linking. [Approximately 2.5 Months]: Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day.

+Eligibility

Sex: All, ages: 13 Years to any

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

+Locations (1)

Facility	City	Country	Status
Glaukos Investigative Site	Westerville, Ohio	United States	Recruiting

+Investigators

Study Director, Study director, Glaukos Corporation