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

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

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

Study Overview

• Status: Recruiting
• Conditions: Progressive Keratoconus
• Intervention / Treatment: Combination product: NXL Energy 3; Combination product: Sham Treatment; Combination product: NXL Energy 1; Combination product: NXL Energy 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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Marco Armijo; Phone Number: 562-761-7965; Email: marmijo@glaukos.com

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Recruiting
      • Glaukos Investigative Site
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Recruiting
      • Glaukos Investigative Site
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Recruiting
      • Glaukos Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1; 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
Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A; 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: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A; 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: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A; 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
Active Comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B; 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: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B; 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: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B; 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: Placebo Group 2 / Cohort 2B; Sham Solution with no exposure to NXL System	Combination product: Sham Treatment; Sham Drops and No exposure to NXL system

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Keratoconus; Eye rubbing; Collagen cross-linking; Progressive Keratoconus
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: NXL-101-KCON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes