Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus

NCT03442751 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: ACP-KXL-308
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.

Conditions

Progressive Keratoconus

Outcome Measures

Primary Outcomes (1)

• Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax

  Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups

  6 months

Secondary Outcomes (1)

• Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax

  12 months

Study Arms (2)

Epithelium-on CXL Treatment Group

EXPERIMENTAL

Study eye receives Test Article A, Test Article B, and exposed to cross-linking dose of UVA light generated by the KXL medical device system

Drug: Test Article A; Drug: Test Article B; Device: KXL medical device system

Sham Treatment/Control Group

SHAM COMPARATOR

Sham eye receives Placebo and and exposed to mock dose of UVA light generated by the KXL medical device system

Drug: Placebo; Device: KXL medical device system

Interventions

Test Article A DRUG

Riboflavin Ophthalmic Solution A

Epithelium-on CXL Treatment Group

Test Article B DRUG

Riboflavin Ophthalmic Solution B

Epithelium-on CXL Treatment Group

Placebo DRUG

Placebo Vehicle of Test Article

Sham Treatment/Control Group

KXL medical device system DEVICE

Mock UVA light source

Sham Treatment/Control Group

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be between 12 and 55 years of age, male or female, of any race;
• Provide written informed consent and sign a HIPAA form. Subjects who are under the age of 18 (or have not yet reached the age of majority per local regulations) will need to sign an assent form as well as having a parent or legal guardian sign an informed consent
• Ability to read English or Spanish to complete the NEI-VFQ 25 questionnaire;
• Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
• For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of each study eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
• Having topographic and clinical evidence of keratoconus

You may not qualify if:

• Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
• If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
• Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
• A history of delayed epithelial healing in the eye to be treated or a current condition that may interfere with or prolong epithelial healing;
• A history of previous corneal cross-linking treatment in the eye to be treated;
• Have used an investigational drug or device within 30 days of screening or be concurrently enrolled in another investigational drug or device trial within 30 days of the study.

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Ophthalmic Consultants of Boston

Waltham, Massachusetts, 02451, United States

Location

Results Point of Contact

• Title: Valerie Smith
• Organization: Glaukos

VSmith@glaukos.com

9493679600

Study Officials

• Valerie Smith

  Glaukos Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization was by eye (active or sham). However an individual participant could receive active/active, active/untreated, sham/sham, sham/untreated or active/sham

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: April 6, 2018
• Primary Completion: November 1, 2019
• Study Completion: August 10, 2020
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)