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NCT Number: NCT07629557

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

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

Recruiting

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaukos Investigative Site

Westerville, Ohio, 43082, United States

Location status: Recruiting

Location contact

Study Director, MD

CONTACT

[email protected]

949-739-8749

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riboflavin Ophthalmic Solutions

Drug

Riboflavin Ophthalmic Solutions

UV-A Irradiation System

Device

O2n UV-A Irradiation System

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

949-739-8749

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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