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

Sponsor
Glaukos Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05314738
Collaborator
(none)
150
Enrollment
4
Locations
5
Arms
37.8
Anticipated Duration (Months)
37.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: NXL Energy 1
  • Combination Product: NXL Energy 2
  • Combination Product: NXL Energy 3
  • Combination Product: Sham Treatment
 Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 / Cohort 1

Blind/Partially sited eyes Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Combination Product: NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3
Sham Comparator: Group 2 / Cohort 2

Sham Solution with no exposure to NXL System

Combination Product: Sham Treatment
Sham Drops and No exposure to NXL system
Active Comparator: Group 3 / Cohort 2

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

Combination Product: NXL Energy 1
Riboflavin drops + NXL System to Total Energy Level 1
Active Comparator: Group 4 / Cohort 2

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

Combination Product: NXL Energy 2
Riboflavin drops + NXL System to Total Energy Level 2
Active Comparator: Group 5 / Cohort 2

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

Combination Product: NXL Energy 3
Riboflavin drops + NXL System to Total Energy Level 3

Outcome Measures

Primary Outcome Measures

  1. Topography [6 Months]

    Change in Kmax topography value from baseline

Secondary Outcome Measures

  1. Distance Uncorrected Visual Acuity (UCVA) [6 Months]

    Change in Distance UCVA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Provide written informed consent

  • Ability to hold gaze sufficiently stable for study testing

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glaukos Investigative Site Dothan Alabama United States 36301
2 Glaukos Investigative Site Boston Massachusetts United States 02114
3 Glaukos Investigative Site Teaneck New Jersey United States 07666
4 Glaukos Investigative Site Westerville Ohio United States 43082

Sponsors and Collaborators

  • Glaukos Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT05314738
Other Study ID Numbers:
  • NXL-101-KCON
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Glaukos Corporation
Eye rubbing
Collagen cross-linking
Keratoconus
Progressive Keratoconus
Additional relevant MeSH terms:
Keratoconus

Study Results

No Results Posted as of Apr 6, 2022