RecruitingPhase 4NCT07629557

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

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

Sponsor

Glaukos Corporation

Enrollment

15 participants

Start Date

May 11, 2026

Study Type

INTERVENTIONAL

Conditions

Keratoconus

Summary

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

Eligibility

Min Age: 13 Years

Inclusion Criteria3

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

Exclusion Criteria5

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

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Interventions

DRUGRiboflavin Ophthalmic Solutions

Riboflavin Ophthalmic Solutions

DEVICEUV-A Irradiation System

O2n UV-A Irradiation System

Locations(1)

Glaukos Investigative Site

Westerville, Ohio, United States

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NCT07629557

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