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
| Arm | Description | Assigned 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® |
|
Recruiting Locations
Glaukos Investigative Site
Westerville, Ohio 43082
Westerville, Ohio 43082
More Details
- Status
- Recruiting
- Sponsor
- Glaukos Corporation