NCT07629557

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
15mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
May 2026Sep 2027

Study Start

First participant enrolled

May 11, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Keratoconus

Keywords

KeratoconusCorneal Cross-linking

Outcome Measures

Primary Outcomes (1)

  • Successful completion of bilateral epithelium-on corneal collagen cross-linking.

    Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day.

    Approximately 2.5 Months

Study Arms (1)

Epioxa™ HD/Epioxa™ and UV-A Irradiation

EXPERIMENTAL

Epioxa™ HD/Epioxa™ and UV-A Irradiation using the O2n™ System and Supplemental Oxygen using the Boost Goggles®

Drug: Riboflavin Ophthalmic SolutionsDevice: UV-A Irradiation System

Interventions

Riboflavin Ophthalmic SolutionsDRUG

Riboflavin Ophthalmic Solutions

Epioxa™ HD/Epioxa™ and UV-A Irradiation
UV-A Irradiation SystemDEVICE

O2n UV-A Irradiation System

Epioxa™ HD/Epioxa™ and UV-A Irradiation

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaukos Investigative Site

Westerville, Ohio, 43082, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Study Director

    Glaukos Corporation

    STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

949-739-8749ClinicalResearch@glaukos.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

May 11, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)