Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
NCT ID: NCT05314738
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2022-03-08
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
NXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
NXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
NXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
NXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
Placebo Group 2 / Cohort 2B
Sham Solution with no exposure to NXL System
Sham Treatment
Sham Drops and No exposure to NXL system
Interventions
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NXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
NXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
Sham Treatment
Sham Drops and No exposure to NXL system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Locations
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Glaukos Investigative Site
Dothan, Alabama, United States
Glaukos Investigative Site
Teaneck, New Jersey, United States
Glaukos Investigative Site
Westerville, Ohio, United States
Countries
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Central Contacts
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Other Identifiers
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NXL-101-KCON
Identifier Type: -
Identifier Source: org_study_id
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