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Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

Primary Purpose

Keratoconus, Corneal Ectasia

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Riboflavin

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, corneal ectasia, collagen crosslinking, riboflavin, crosslinking, corneal crosslinking

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

12 years of age or older
Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK])
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 lenses 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:

Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
Corneal pachymetry measuring 300 microns or less 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:
1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
2. Clinically significant corneal scaring 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

Sites / Locations

Cornea and Laser Eye Institute, Hersh Vision GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Riboflavin drop every 2 minutes

Riboflavin drop every 10 minutes

Arm Description

Administration of one drop of Riboflavin every 2 minutes during UV exposure

Administration of one drop of Riboflavin every 10 minutes during UV exposure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean keratometry

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

Full Information

NCT ID

NCT04905108

First Posted

May 24, 2021

Last Updated

December 30, 2022

Sponsor

Cornea and Laser Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT04905108

Brief Title

Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

Official Title

Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Two Different Riboflavin Administration Protocols

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 2, 2021 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cornea and Laser Eye Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.

Detailed Description

The objective of this randomized study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with two different riboflavin administration protocols during the UVA portion of the procedure. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, the two groups will be compared with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, and slit lamp examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus, Corneal Ectasia

Keywords

keratoconus, corneal ectasia, collagen crosslinking, riboflavin, crosslinking, corneal crosslinking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Riboflavin drop every 2 minutes

Arm Type

Active Comparator

Arm Description

Administration of one drop of Riboflavin every 2 minutes during UV exposure

Arm Title

Riboflavin drop every 10 minutes

Arm Type

Active Comparator

Arm Description

Administration of one drop of Riboflavin every 10 minutes during UV exposure

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Intervention Description

Administration of riboflavin one drop every 2 minutes during UVA exposure

Intervention Type

Drug

Intervention Name(s)

Riboflavin

Intervention Description

Administration of riboflavin one drop every 10 minutes during UVA exposure

Primary Outcome Measure Information:

Title

Maximum keratometry

Description

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 Outcome Measure Information:

Title

Mean keratometry

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 12 years of age or older Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK]) 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 lenses 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: Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme Corneal pachymetry measuring 300 microns or less 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 scaring 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

BethAnn Furlong-HIbbert

Phone

(201) 692-9434

bfurlong-hibbert@vision-institute.com

First Name & Middle Initial & Last Name or Official Title & Degree

Stacey Lazar

Phone

(201) 692-9434

slazar@vision-institute.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter S Hersh, MD

Organizational Affiliation

Cornea and Laser Eye Institute - Hersh Vision Group

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Steven A Greenstein, MD

Organizational Affiliation

Cornea and Laser Eye Institute - Hersh Vision Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cornea and Laser Eye Institute, Hersh Vision Group

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

BethAnn Hibbert

Phone

201-692-9434

bfurlong-hibbert@vision-institute.com

First Name & Middle Initial & Last Name & Degree

Stacey Lazar

Phone

201 692-434

slazar@vision-institute.om

First Name & Middle Initial & Last Name & Degree

Peter S Hersh, MD

First Name & Middle Initial & Last Name & Degree

Steven A Greenstein, MD

12. IPD Sharing Statement

Learn more about this trial

Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

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