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

Purpose

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

Condition

  • Keratoconus

Eligibility

Eligible Ages
Over 13 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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®
  • Drug: Riboflavin Ophthalmic Solutions
    Riboflavin Ophthalmic Solutions
  • Device: UV-A Irradiation System
    O2n UV-A Irradiation System

Recruiting Locations

Glaukos Investigative Site
Westerville, Ohio 43082
Contact:
Study Director, MD
949-739-8749
ClinicalResearch@glaukos.com

More Details

Status
Recruiting
Sponsor
Glaukos Corporation

Study Contact

Study Director
949-739-8749
ClinicalResearch@glaukos.com