NCT05314738

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

3.4 years

First QC Date

March 29, 2022

Last Update Submit

July 4, 2024

Conditions

Progressive Keratoconus

Keywords

Eye rubbingCollagen cross-linkingKeratoconusProgressive Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Topography

    Change in Kmax topography value from baseline

    12 Months

Secondary Outcomes (1)

  • Distance Uncorrected Visual Acuity (UCVA)

    12 Months

Study Arms (8)

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

EXPERIMENTAL

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

Combination Product: NXL Energy 3

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

ACTIVE COMPARATOR

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

Combination Product: NXL Energy 1

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

ACTIVE COMPARATOR

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

Combination Product: NXL Energy 2

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

ACTIVE COMPARATOR

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

Combination Product: NXL Energy 3

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

ACTIVE COMPARATOR

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

Combination Product: NXL Energy 1

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

ACTIVE COMPARATOR

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

Combination Product: NXL Energy 2

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

ACTIVE COMPARATOR

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

Combination Product: NXL Energy 3

Placebo Group 2 / Cohort 2B

SHAM COMPARATOR

Sham Solution with no exposure to NXL System

Combination Product: Sham Treatment

Interventions

NXL Energy 1COMBINATION_PRODUCT

Riboflavin drops + NXL System to Total Energy Level 1

Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2ARiboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B
NXL Energy 2COMBINATION_PRODUCT

Riboflavin drops + NXL System to Total Energy Level 2

Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2ARiboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B
NXL Energy 3COMBINATION_PRODUCT

Riboflavin drops + NXL System to Total Energy Level 3

Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2ARiboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B
Sham TreatmentCOMBINATION_PRODUCT

Sham Drops and No exposure to NXL system

Placebo Group 2 / Cohort 2B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Glaukos Investigative Site

Dothan, Alabama, 36301, United States

RECRUITING

Glaukos Investigative Site

Teaneck, New Jersey, 07666, United States

RECRUITING

Glaukos Investigative Site

Westerville, Ohio, 43082, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Marco Armijo

CONTACT

562-761-7965marmijo@glaukos.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 6, 2022

Study Start

March 8, 2022

Primary Completion

August 1, 2025

Study Completion

February 1, 2026

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)