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NCT Number: NCT05314738

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

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

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Key information

Conditions

Progressive Keratoconus Corneal Diseases Eye Diseases Keratoconus

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Glaukos Investigative Site, Dothan, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 for follow-up visits
  • Have a diagnosis of keratoconus

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 may predispose the eye for future complications

Treatment and study plan

NXL Energy 1

Combination Product

Riboflavin drops + NXL System to Total Energy Level 1

NXL Energy 2

Combination Product

Riboflavin drops + NXL System to Total Energy Level 2

NXL Energy 3

Combination Product

Riboflavin drops + NXL System to Total Energy Level 3

Sham Treatment

Combination Product

Sham Drops and No exposure to NXL system

Primary outcomes

  1. Topography

    Time frame: 12 Months

    Change in Kmax topography value from baseline

Secondary outcomes

  1. Distance Uncorrected Visual Acuity (UCVA)

    Time frame: 12 Months

    Change in Distance UCVA

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Armijo

CONTACT

[email protected]

562-761-7965

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2022
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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