Recruiting

Corneal Cross-Linking

Sponsor:

Glaukos Corporation

Code:

NCT07629557

Conditions

Keratoconus

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Riboflavin Ophthalmic Solutions

UV-A Irradiation System

Study Details

Brief summary:

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

Conditions

Keratoconus

Study ID

NCT07629557

Start date

May 11, 2026

Status verified date

Jun, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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®

Interventions

Riboflavin Ophthalmic Solutions

Riboflavin Ophthalmic Solutions

UV-A Irradiation System

O2n UV-A Irradiation System

Primary outcome measure

  • Successful completion of bilateral epithelium-on corneal collagen cross-linking. [ Time Frame: Approximately 2.5 Months ]

Central Contacts and Locations

Central contacts

Study Director

949-739-8749ClinicalResearch@glaukos.com

Locations

Glaukos Investigative Site

Recruiting

Westerville, Ohio, United States, 43082

Contacts

Study Director, MD

949-739-8749ClinicalResearch@glaukos.com

More Information

Sponsor

Glaukos Corporation

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Keratoconus
  • Corneal Cross-linking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2026-06-05.