Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Cxlusa

Status and phase: Terminated; Phase 2

Conditions: Photosensitizing Agents; Keratoconus; Corneal Diseases; Eye Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03029104

CXL-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,228 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,228 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device

Group 2

Active Comparator group

Description:

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.

Treatment:

Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device

Group 3

Active Comparator group

Description:

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.

Treatment:

Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device