RecruitingPhase 1Phase 2NCT05314738

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

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


Sponsor

Glaukos Corporation

Enrollment

150 participants

Start Date

Mar 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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

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Interventions

COMBINATION_PRODUCTNXL Energy 1

Riboflavin drops + NXL System to Total Energy Level 1

COMBINATION_PRODUCTNXL Energy 2

Riboflavin drops + NXL System to Total Energy Level 2

COMBINATION_PRODUCTNXL Energy 3

Riboflavin drops + NXL System to Total Energy Level 3

COMBINATION_PRODUCTSham Treatment

Sham Drops and No exposure to NXL system


Locations(3)

Glaukos Investigative Site

Dothan, Alabama, United States

Glaukos Investigative Site

Teaneck, New Jersey, United States

Glaukos Investigative Site

Westerville, Ohio, United States

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NCT05314738


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