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

Primary Purpose

Progressive Keratoconus

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NXL Energy 1

NXL Energy 2

NXL Energy 3

Sham Treatment

About this trial

This is an interventional treatment trial for Progressive Keratoconus focused on measuring Eye rubbing, Collagen cross-linking, Keratoconus, Progressive Keratoconus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide written informed consent
Ability to hold gaze sufficiently stable for study testing

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

Sites / Locations

Glaukos Investigative SiteRecruiting
Glaukos Investigative SiteRecruiting
Glaukos Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

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

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

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

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

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

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

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

Placebo Group 2 / Cohort 2B

Arm Description

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

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

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

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

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

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

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

Sham Solution with no exposure to NXL System

Outcomes

Primary Outcome Measures

Topography

Change in Kmax topography value from baseline

Secondary Outcome Measures

Distance Uncorrected Visual Acuity (UCVA)

Change in Distance UCVA

Full Information

NCT ID

NCT05314738

First Posted

March 29, 2022

Last Updated

July 25, 2023

Sponsor

Glaukos Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05314738

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 8, 2022 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Glaukos Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Keratoconus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo Group 2 / Cohort 2B

Arm Type

Sham Comparator

Arm Description

Sham Solution with no exposure to NXL System

Intervention Type

Combination Product

Intervention Name(s)

NXL Energy 1

Intervention Description

Riboflavin drops + NXL System to Total Energy Level 1

Intervention Type

Combination Product

Intervention Name(s)

NXL Energy 2

Intervention Description

Riboflavin drops + NXL System to Total Energy Level 2

Intervention Type

Combination Product

Intervention Name(s)

NXL Energy 3

Intervention Description

Riboflavin drops + NXL System to Total Energy Level 3

Intervention Type

Combination Product

Intervention Name(s)

Sham Treatment

Intervention Description

Sham Drops and No exposure to NXL system

Primary Outcome Measure Information:

Title

Topography

Description

Change in Kmax topography value from baseline

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Distance Uncorrected Visual Acuity (UCVA)

Description

Change in Distance UCVA

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco Armijo

Phone

562-761-7965

marmijo@glaukos.com

Facility Information:

Facility Name

Glaukos Investigative Site

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36301

Country

United States

Individual Site Status

Recruiting

Facility Name

Glaukos Investigative Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Individual Site Status

Recruiting

Facility Name

Glaukos Investigative Site

City

Westerville

State/Province

Ohio

ZIP/Postal Code

43082

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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