Epi-On Corneal Crosslinking for Keratoconus

NCT ID: NCT03245853

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-18
• Study Completion Date: 2019-09-30

Brief Summary

Epithelium-On Corneal Crosslinking for Keratoconus.

Detailed Description

Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination.

The primary efficacy parameter is the change from baseline over time in maximum keratometry (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA).

Conditions

Keratoconus; Keratoconus, Unstable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Treatment as per protocol, there is no placebo arm.

Group Type: OTHER

Riboflavin 5'-Phosphate

Intervention Type: DRUG

Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg \[0.12%\] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.

Interventions

Riboflavin 5'-Phosphate

Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg \[0.12%\] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.

Intervention Type: DRUG

Other Intervention Names

Photrexa

Eligibility Criteria

Inclusion Criteria

• 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria

• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to become pregnant, or lactation during study. Corneal pachymetry <350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.

Nystagmus or any other condition that would prevent steady gaze. Other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: collaborator

Comprehensive EyeCare of Central Ohio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth A Beckman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Comprehensive EyeCare of Central Ohio

Locations

Comprehensive EyeCare of Central Ohio

Westerville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20170265

Identifier Type: -

Identifier Source: org_study_id