Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Phase 2

Terminated

• Conditions: Eye Diseases; Keratoconus; Corneal Diseases; Photosensitizing Agents
• Interventions: Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device

• Registration Number: NCT03029104
• Lead Sponsor: Cxlusa

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-12-21
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Primary Completion: 2020-12-27
• Study Completion: 2020-12-27
• Results First Submitted: 2021-11-14
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-15
• Last Update Submitted: 2021-12-15
• Results First Posted: 2022-01-12
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2228

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	CXLO Corneal Strengthening Solution and UVA Illumination Device	Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
Group 3	CXLO Corneal Strengthening Solution and UVA Illumination Device	Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
Group 1	CXLO Corneal Strengthening Solution and UVA Illumination Device	Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Corrected Distance Visual Acuity (CDVA)	Baseline and 6 and 12 months	Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)	Baseline and 6 and 12 months	Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline
Change From Baseline in Maximum Keratometry (KMax)	Baseline and 6 and 12 months	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.

Trial Locations

Locations (9)

Schwartz Laser Eye Center; 🇺🇸 Scottsdale, Arizona, United States

Chicago Cornea Consultants; 🇺🇸 Chicago, Illinois, United States

Woolfson Eye Institute; 🇺🇸 Atlanta, Georgia, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Goodman Eye Center; 🇺🇸 San Francisco, California, United States

Cornea Consultants of Colorado; 🇺🇸 Littleton, Colorado, United States

Ophthalmology Associates; 🇺🇸 Saint Louis, Missouri, United States

Cornea Associates of Texas; 🇺🇸 Dallas, Texas, United States

Chicago Cornea Consultants, Ltd.; 🇺🇸 Hoffman Estates, Illinois, United States