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RecruitingNCT04897503CXLUpdated Jan 4, 2023

Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

A Phase 3 interventional study of Riboflavin in Keratoconus and Corneal Ectasia, sponsored by Cornea and Laser Eye Institute. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Cornea and Laser Eye Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

Read the detailed description

This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution. Both groups will be exposed to 3mW/cm2 of continuous UVA light for a total of 30 minutes; each group will continue to be administered the designated riboflavin drops during UV exposure.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group.

The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline.

02

Conditions studied

  • Keratoconus
  • Corneal Ectasia

Keywords

  • keratoconus
  • corneal ectasia
  • collagen crosslinking
  • riboflavin
  • cornea
  • ultraviolet
  • crosslinking
  • corneal crosslinking
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 12 years of age or older
  • Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
  • Presence of central or inferior steepening on the Pentacam map
  • Axial topography consistent with keratoconus or post-surgical corneal ectasia
  • Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction
  • Signed written informed consent
  • Willingness and ability to comply with schedule for follow-up visits

Exclusion criteria

Exclusion Criteria:

  • Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
  • Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated
  • Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL treatment zone
  • A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
  • Pregnancy (including plan to become pregnant) or lactation during the course of the study
  • A known sensitivity to study medications
  • Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
  • Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Active comparator
    CXL using Riboflavin/Dextran solution

    Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran

    Drug: Riboflavin

  • Active comparator
    CXL usinng Riboflavin/Methylcellulose solution

    Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)

    Drug: Riboflavin

Interventions

  • DrugRiboflavin

    Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.

05

What researchers measure

Primary outcomes

  1. Maximum keratometry

    The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

    Time frame: 12 months

Secondary outcomes

  1. Visual acuity

    Change in uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BCVA) compared to the baseline examination will be evaluated at 12 months postoperatively.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT04897503
Lead sponsor
Cornea and Laser Eye Institute
Responsible party
Sponsor
First posted
May 21, 2021
Start date
Apr 16, 2021
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 4, 2023

Study contacts

BethAnn Furlong-Hibbert
Contact
bafhibbert@yahoo.com
1 201 692-9434
Stacey Lazar
Contact
slazar@vision-institute.com
1 201 692-9434
Peter S Hersh, MD
study director · Cornea and Laser Eye Institute Hersh Vision Group
Steven A Greenstein, MD
principal investigator · Cornea and Laser Eye Institute, Hersh Vision Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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