Study detail
RecruitingPhase 4
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
Glaukos Corporation
Summary
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
Eligibility
- Age range
- 13+ years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
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
Interventions
- DrugRiboflavin Ophthalmic Solutions
Riboflavin Ophthalmic Solutions
- DeviceUV-A Irradiation System
O2n UV-A Irradiation System
Location
- Glaukos Investigative SiteWesterville, Ohio