Brief Summary

This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

Trial Health

Monitor

Trial Health Score

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

Enrollment

2,228

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2016

Typical duration for phase_2

Geographic Reach

1 country

9 active sites

Status

terminated

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

4 years study duration

Study Start

First participant enrolled

December 21, 2016

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2020

Completed

1 year until next milestone

Results Posted

Study results publicly available

January 12, 2022

Completed

Last Updated

January 12, 2022

Status Verified

December 1, 2021

Enrollment Period

4 years

First QC Date

January 20, 2017

Results QC Date

November 14, 2021

Last Update Submit

December 15, 2021

Conditions

Keratoconus Corneal Diseases Eye Diseases Photosensitizing Agents

Keywords

KeratoconusForme fruste keratoconusPost-LASIK ectasiaPellucid marginal degenerationForme fruste pellucid marginal degenerationDiurnal fluctuation post-radial keratotomyTerrien's marginal degeneration

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Corrected Distance Visual Acuity (CDVA)
Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline
Baseline and 6 and 12 months

Secondary Outcomes (2)

Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
Baseline and 6 and 12 months
Change From Baseline in Maximum Keratometry (KMax)
Baseline and 6 and 12 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.

Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device

Group 2

ACTIVE COMPARATOR

Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.

Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device

Group 3

ACTIVE COMPARATOR

Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.

Combination Product: CXLO Corneal Strengthening Solution and UVA Illumination Device

Interventions

CXLO Corneal Strengthening Solution and UVA Illumination DeviceCOMBINATION_PRODUCT

CXLO Corneal Strengthening Solution

Group 1Group 2Group 3

Eligibility Criteria

Age8 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

A diagnosis of at least one of the following conditions:
Keratoconus
Forme fruste keratoconus
Post-LASIK ectasia
Pellucid marginal degeneration
Forme fruste pellucid marginal degeneration
Diurnal fluctuation post-radial keratotomy
Terrien's marginal degeneration

You may not qualify if:

Corneal thickness \< 375 microns measured by ultrasound or Pentacam.
Contraindications or hypersensitivities to any study medications or their components.
Pregnancy or breastfeeding.
Any history of herpes simplex corneal disease in an eye to be treated.
Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
Inability to cooperate with diagnostic tests.
Enrollment in another ophthalmic clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cxlusalead

Study Sites (9)

Schwartz Laser Eye Center

Scottsdale, Arizona, 85260, United States

Location

Goodman Eye Center

San Francisco, California, 94115, United States

Location

Cornea Consultants of Colorado

Littleton, Colorado, 80120-4508, United States

Location

Woolfson Eye Institute

Atlanta, Georgia, 30328, United States

Location

Chicago Cornea Consultants

Chicago, Illinois, 60035, United States

Location

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, 60169, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63110, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Cornea Associates of Texas

Dallas, Texas, 75231, United States

Location

Related Publications (1)

Epstein RJ, Belin MW, Gravemann D, Littner R, Rubinfeld RS. EpiSmart Crosslinking for Keratoconus: A Phase 2 Study. Cornea. 2023 Jul 1;42(7):858-866. doi: 10.1097/ICO.0000000000003136. Epub 2022 Sep 28.
PMID: 36173242DERIVED

MeSH Terms

Conditions

KeratoconusCorneal DiseasesEye Diseases

Results Point of Contact

Title: Chief Clinical Development Officer
Organization: CXL Ophthalmics, LLC

Study Officials

Gregg J Berdy, MD, FACS
Ophthalmology Associates, St. Louis, MO
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Masking Details: Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

December 21, 2016

Primary Completion

December 27, 2020

Study Completion

December 27, 2020

Last Updated

January 12, 2022

Results First Posted

January 12, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing: Will not share

Locations

US(9)

Study Stopped

Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

Group 1

Group 2

Group 3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

Group 1

Group 2

Group 3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (9)

Related Publications (1)

MeSH Terms

Conditions

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations