Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Status and phase
Enrolling
Phase 2
Phase 1
Conditions
Progressive Keratoconus
Treatments
Combination Product: NXL Energy 2
Combination Product: Sham Treatment
Combination Product: NXL Energy 1
Combination Product: NXL Energy 3
Details and patient eligibility
About
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Full 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.
Enrollment
150 estimated patients
Sex
All
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
150 participants in 8 patient groups
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1
Experimental group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Treatment:
Combination Product: NXL Energy 3
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A
Active Comparator group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Treatment:
Combination Product: NXL Energy 1
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A
Active Comparator group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Treatment:
Combination Product: NXL Energy 2
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A
Active Comparator group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Treatment:
Combination Product: NXL Energy 3
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B
Active Comparator group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Treatment:
Combination Product: NXL Energy 1
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B
Active Comparator group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Treatment:
Combination Product: NXL Energy 2
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B
Active Comparator group
Description:
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Treatment:
Combination Product: NXL Energy 3
Placebo Group 2 / Cohort 2B
Sham Comparator group
Description:
Sham Solution with no exposure to NXL System
Treatment:
Combination Product: Sham Treatment
Trial contacts and locations
3
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Central trial contact
Marco Armijo
Data sourced from clinicaltrials.gov
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