Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
NCT05314738 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2024-07-08
Summary
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Conditions
- Progressive Keratoconus
Interventions
- 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
Sponsors & Collaborators
-
Glaukos Corporation
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-08
- Primary Completion
- 2025-08-31
- Completion
- 2026-02-28
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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