RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
About This Trial
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Who May Be Eligible (Plain English)
Who May Qualify:
- Provide written willing to sign a consent form
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
COMBINATION_PRODUCT
NXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
COMBINATION_PRODUCT
NXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
COMBINATION_PRODUCT
NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
COMBINATION_PRODUCT
Sham Treatment
Sham Drops and No exposure to NXL system
Locations (3)
Glaukos Investigative Site
Dothan, Alabama, United States
Glaukos Investigative Site
Teaneck, New Jersey, United States
Glaukos Investigative Site
Westerville, Ohio, United States