Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Study Overview
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Brief Summary
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Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

Detailed Description
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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.

Official Title
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A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Conditions
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Progressive Keratoconus

Intervention / Treatment
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* Combination Product: NXL Energy 1
* Combination Product: NXL Energy 2
* Combination Product: NXL Energy 3
* Combination Product: Sham Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 | Combination Product: NXL Energy 3<br>* Riboflavin drops + NXL System to Total Energy Level 3<br>|
| Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 | Combination Product: NXL Energy 1<br>* Riboflavin drops + NXL System to Total Energy Level 1<br>|
| Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 | Combination Product: NXL Energy 2<br>* Riboflavin drops + NXL System to Total Energy Level 2<br>|
| Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 | Combination Product: NXL Energy 3<br>* Riboflavin drops + NXL System to Total Energy Level 3<br>|
| Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 1 | Combination Product: NXL Energy 1<br>* Riboflavin drops + NXL System to Total Energy Level 1<br>|
| Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 2 | Combination Product: NXL Energy 2<br>* Riboflavin drops + NXL System to Total Energy Level 2<br>|
| Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B<br>Riboflavin Solution + Exposure to NXL system to achieve total energy level 3 | Combination Product: NXL Energy 3<br>* Riboflavin drops + NXL System to Total Energy Level 3<br>|
| Sham Comparator: Placebo Group 2 / Cohort 2B<br>Sham Solution with no exposure to NXL System | Combination Product: Sham Treatment<br>* Sham Drops and No exposure to NXL system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topography | Change in Kmax topography value from baseline | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Uncorrected Visual Acuity (UCVA) | Change in Distance UCVA | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye rubbing, Collagen cross-linking, Keratoconus, Progressive Keratoconus