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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1 		Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
  • Combination Product: NXL Energy 3
    Riboflavin drops + NXL System to 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
  • Combination Product: NXL Energy 1
    Riboflavin drops + NXL System to 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
  • Combination Product: NXL Energy 2
    Riboflavin drops + NXL System to 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
  • Combination Product: NXL Energy 3
    Riboflavin drops + NXL System to 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
  • Combination Product: NXL Energy 1
    Riboflavin drops + NXL System to 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
  • Combination Product: NXL Energy 2
    Riboflavin drops + NXL System to 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
  • Combination Product: NXL Energy 3
    Riboflavin drops + NXL System to Total Energy Level 3
Sham Comparator
Placebo Group 2 / Cohort 2B 		Sham Solution with no exposure to NXL System
  • Combination Product: Sham Treatment
    Sham Drops and No exposure to NXL system

Recruiting Locations

Glaukos Investigative Site
Dothan, Alabama 36301

Glaukos Investigative Site
Teaneck, New Jersey 07666

Glaukos Investigative Site
Westerville, Ohio 43082

More Details

Status
Recruiting
Sponsor
Glaukos Corporation

Study Contact

Marco Armijo
562-761-7965
marmijo@glaukos.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.