Progressive Keratoconus
Conditions
Keywords
Eye rubbing, Collagen cross-linking, Keratoconus, Progressive Keratoconus
Brief summary
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Detailed description
This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.
Interventions
COMBINATION_PRODUCTNXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
COMBINATION_PRODUCTNXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
COMBINATION_PRODUCTNXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
COMBINATION_PRODUCTSham Treatment
Sham Drops and No exposure to NXL system
Sponsors
Glaukos Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent * Ability to hold gaze sufficiently stable for study testing * Willingness and ability to follow all instructions and comply with schedule for follow-up visits * Have a diagnosis of keratoconus
Exclusion criteria
* Known allergy or sensitivity to the test articles or components * Any disease causing abnormal topography other than keratoconus * Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Topography | 12 Months | Change in Kmax topography value from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance Uncorrected Visual Acuity (UCVA) | 12 Months | Change in Distance UCVA |
Countries
United States
Contacts
Primary ContactMarco Armijo
Outcome results
None listed