Corneal Collagen Cross-linking for Progressive Keratoconus

Phase 3

Completed

• Conditions: Progressive Keratoconus
• Interventions: Drug: riboflavin ophthalmic solution; Device: UVA Irradiation

• Registration Number: NCT00647699
• Lead Sponsor: Glaukos Corporation

Brief Summary

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Detailed Description

This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Disposition First Submitted: 2012-05-18
• Disposition First Submitted QC: 2012-05-18
• Disposition First Posted: 2012-05-30
• Results First Submitted: 2016-05-02
• Results First Submitted QC: 2016-06-14
• Results First Posted: 2016-07-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• Diagnosis of keratoconus
• Documented progression over previous 24 months
• Decreased BSCVA
• Must complete all study visits

Exclusion Criteria

• Prior corneal surgery or Intacs
• History of delayed wound healing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	riboflavin ophthalmic solution	riboflavin ophthalmic solution without UVA irradiation.
Corneal Collagen Cross-linking (CXL) Treatment Group	riboflavin ophthalmic solution	riboflavin ophthalmic solution and UVA irradiation
Corneal Collagen Cross-linking (CXL) Treatment Group	UVA Irradiation	riboflavin ophthalmic solution and UVA irradiation

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Maximum Keratometry (Kmax)	baseline,12 months	The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.

Trial Locations

Locations (10)

Cornea & Laser Eye Institute; Hersh Vision Group; 🇺🇸 Teaneck, New Jersey, United States

Durrie Vision; 🇺🇸 Kansas City, Kansas, United States

Shiley Eye Center; 🇺🇸 La Jolla, California, United States

Gordon -Weiss Vision Institute; 🇺🇸 San Diego, California, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Wilmer Eye Institute at Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Minnesota Eye Consultants; 🇺🇸 Minneapolis, Minnesota, United States

Edward Harkness Eye Institute at Columbia University Medical Center; 🇺🇸 New York, New York, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Rockville Centre, New York, United States