Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Last updated: July 4, 2024
Sponsor: Glaukos Corporation
Overall Status: Active - Recruiting

Phase

1/2

Condition

Eye Disease

Vision Loss

Treatment

NXL Energy 1

Sham Treatment

NXL Energy 2

Clinical Study ID

NCT05314738
NXL-101-KCON
  • Ages 18-55
  • All Genders

Study Summary

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide written informed consent

  • Ability to hold gaze sufficiently stable for study testing

  • Willingness and ability to follow all instructions and comply with schedule forfollow-up visits

  • Have a diagnosis of keratoconus

Exclusion

Exclusion Criteria:

  • Known allergy or sensitivity to the test articles or components

  • Any disease causing abnormal topography other than keratoconus

  • Prior or current ocular condition (other than keratoconus) in the study eye that maypredispose the eye for future complications

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: NXL Energy 1
Phase: 1/2
Study Start date:
March 08, 2022
Estimated Completion Date:
February 28, 2026

Study Description

This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.

Connect with a study center

  • Glaukos Investigative Site

    Dothan, Alabama 36301
    United States

    Active - Recruiting

  • Glaukos Investigative Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Glaukos Investigative Site

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • Glaukos Investigative Site

    Westerville, Ohio 43082
    United States

    Active - Recruiting

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