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NCT05314738 Clinical Trial

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

Progressive Keratoconus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05314738
Other study ID # NXL-101-KCON
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 8, 2022
Est. completion date August 2025

Study information
Verified date July 2023
Source Glaukos Corporation
Contact Marco Armijo
Phone 562-761-7965
Email marmijo@glaukos.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date August 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• 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

Locations
Country Name City State
United States Glaukos Investigative Site Dothan Alabama
United States Glaukos Investigative Site Teaneck New Jersey
United States Glaukos Investigative Site Westerville Ohio

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Topography Change in Kmax topography value from baseline 12 Months
Secondary Distance Uncorrected Visual Acuity (UCVA) Change in Distance UCVA 12 Months
See also
  Status Clinical Trial Phase
Recruiting NCT02721628 - Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus N/A
Completed NCT02883868 - Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency? N/A
Active, not recruiting NCT04427956 - Corneal Crosslinking Treatment Study Phase 4
Terminated NCT01868620 - Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. N/A
Completed NCT02117999 - Transepithelial Corneal Cross-linking Using Iontophoresis N/A
Completed NCT01485211 - Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin Phase 4
Completed NCT04504578 - Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas N/A
Completed NCT00567671 - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia Phase 2/Phase 3
Completed NCT00647699 - Corneal Collagen Cross-linking for Progressive Keratoconus Phase 3
Recruiting NCT00815256 - Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus Phase 3
Recruiting NCT04045626 - Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns N/A
Completed NCT03442751 - Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus Phase 3
Withdrawn NCT00679666 - Corneal Crosslinking in Keratoconus and Corneal Ectasia Phase 2/Phase 3
Completed NCT01411384 - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus N/A
Not yet recruiting NCT00925327 - Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus Phase 2