Recruiting
Phase 1
Phase 2

Corneal Cross-linking

Sponsor:

Glaukos Corporation

Code:

NCT05314738

Conditions

Progressive Keratoconus

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

NXL Energy 1

NXL Energy 2

NXL Energy 3

Sham Treatment

Study Details

Brief summary:

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

Conditions

Progressive Keratoconus

Study ID

NCT05314738

Start date

Mar 8, 2022

Status verified date

Jul, 2024

Completion date

Feb, 2026

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

active comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

active comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

active comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

active comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B

Riboflavin Solution + Exposure to NXL system to achieve total energy level 1

active comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B

Riboflavin Solution + Exposure to NXL system to achieve total energy level 2

active comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B

Riboflavin Solution + Exposure to NXL system to achieve total energy level 3

sham comparator: Placebo Group 2 / Cohort 2B

Sham Solution with no exposure to NXL System

Interventions

NXL Energy 1

Riboflavin drops + NXL System to Total Energy Level 1

NXL Energy 2

Riboflavin drops + NXL System to Total Energy Level 2

NXL Energy 3

Riboflavin drops + NXL System to Total Energy Level 3

Sham Treatment

Sham Drops and No exposure to NXL system

Primary outcome measure

  • Topography [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Marco Armijo

562-761-7965marmijo@glaukos.com

Locations

Glaukos Investigative Site

Recruiting

Dothan, Alabama, United States, 36301

Glaukos Investigative Site

Recruiting

Teaneck, New Jersey, United States, 07666

Glaukos Investigative Site

Recruiting

Westerville, Ohio, United States, 43082

More Information

Sponsor

Glaukos Corporation

Last update posted

Jul 8, 2024

Last verified

Jul, 2024

Keywords

  • Eye rubbing
  • Collagen cross-linking
  • Keratoconus
  • Progressive Keratoconus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Glaukos Corporation on 2024-07-08.