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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03029104
Other study ID # CXL-005
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
See also
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