Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Keratoconus Clinical Trial

Official title:

Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03029104
• Other study ID #: CXL-005
• Status: Terminated
• Phase: Phase 2
• Start date: December 21, 2016
• Est. completion date: December 27, 2020

Study information

• Verified date: December 2021
• Source: Cxlusa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

Description:

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2228
• Est. completion date: December 27, 2020
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of at least one of the following conditions:

1. Keratoconus

2. Forme fruste keratoconus

3. Post-LASIK ectasia

4. Pellucid marginal degeneration

5. Forme fruste pellucid marginal degeneration

6. Diurnal fluctuation post-radial keratotomy

7. Terrien's marginal degeneration

Exclusion Criteria:

1. Corneal thickness < 375 microns measured by ultrasound or Pentacam.

2. Contraindications or hypersensitivities to any study medications or their components.

3. Pregnancy or breastfeeding.

4. Any history of herpes simplex corneal disease in an eye to be treated.

5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.

6. Inability to cooperate with diagnostic tests.

7. Enrollment in another ophthalmic clinical trial.

Related Conditions & MeSH terms

• Corneal Diseases
• Eye Diseases
• Keratoconus
• Photosensitizing Agents

Intervention

Combination Product:
• CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution

Locations

Country	Name	City	State
United States	Woolfson Eye Institute	Atlanta	Georgia
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Chicago Cornea Consultants	Chicago	Illinois
United States	Cornea Associates of Texas	Dallas	Texas
United States	Chicago Cornea Consultants, Ltd.	Hoffman Estates	Illinois
United States	Cornea Consultants of Colorado	Littleton	Colorado
United States	Ophthalmology Associates	Saint Louis	Missouri
United States	Goodman Eye Center	San Francisco	California
United States	Schwartz Laser Eye Center	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cxlusa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Corrected Distance Visual Acuity (CDVA)	Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline	Baseline and 6 and 12 months
Secondary	Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)	Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline	Baseline and 6 and 12 months
Secondary	Change From Baseline in Maximum Keratometry (KMax)	Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline.	Baseline and 6 and 12 months