Trial · NCT03442751

Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus

NCT03442751, Phase 3, Completed, Glaukos Corporation; results first posted 2024-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus. Trials, record NCT03442751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03442751

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
NCT number: NCT03442751
Status: Completed
Phases: Phase 3
Enrollment: 201 participants, actual
Lead sponsor: Glaukos Corporation
Conditions: Progressive Keratoconus
Interventions: Test Article A, Test Article B, Placebo, KXL medical device system, KXL medical device system
First posted: 2018-02-22
Last updated: 2024-01-30
Results first posted: 2024-01-30

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax	6 months	Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
Secondary	Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax	12 months	Difference between the CXL and Sham/Control treatment groups in the change from baseline to Month 12 in Kmax

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax	6 months	Intent-to-treat analysis set which included all randomized study eyes that had at least one post-treatment follow-up efficacy assessment. Missing post-baseline Kmax data were imputed using multiple imputation.	Diopters	LEAST_SQUARES_MEAN
SECONDARY	Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax	12 months	Intent-to-treat analysis set which included all randomized study eyes that had at least one post-treatment follow-up efficacy assessment. Missing post-baseline Kmax data were imputed.	Diopters	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax	Epithelium-on CXL Treatment Group	-0.3	95% Confidence Interval -0.6 to -0.0	Diopters
Difference Between Treatment Groups in the Change From Baseline to Month 6 in Kmax	Sham Treatment/Control Group	0.6	95% Confidence Interval 0.2 to 1.1	Diopters
Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax	Epithelium-on CXL Treatment Group	-0.4	95% Confidence Interval -0.7 to -0.2	Diopters
Difference Between Treatment Groups in the Change From Baseline to Month 12 in Kmax	Sham Treatment/Control Group	0.7	95% Confidence Interval 0.3 to 1.1	Diopters

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	Epithelium-on CXL Treatment Group	156	189
Overall Study	STARTED	Sham Treatment/Control Group	83	90
Overall Study	Month 6	Epithelium-on CXL Treatment Group	153	186
Overall Study	Month 6	Sham Treatment/Control Group	82	89
Overall Study	Month 12	Epithelium-on CXL Treatment Group	150	183
Overall Study	Month 12	Sham Treatment/Control Group	0	0
Overall Study	COMPLETED	Epithelium-on CXL Treatment Group	150	183
Overall Study	COMPLETED	Sham Treatment/Control Group	82	89
Overall Study	NOT COMPLETED	Epithelium-on CXL Treatment Group	6	6
Overall Study	NOT COMPLETED	Sham Treatment/Control Group	1	1

Source ClinicalTrials.gov

Adverse events145

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Conjunctival hyperaemia	Eye disorders	Ocular: Epithelium-on CXL Treatment Group	115	189	120
other	Conjunctival hyperaemia	Eye disorders	Ocular: Sham Treatment/Control Group	25	90	27
other	Conjunctival hyperaemia	Eye disorders	Non-ocular: Epithelium-on	0	118	0
other	Conjunctival hyperaemia	Eye disorders	Non-ocular: Sham Treatment/Control	0	45	0
other	Conjunctival hyperaemia	Eye disorders	Non-ocular: Epithelium-on and Sham Treatment	0	38	0
other	Corneal opacity	Eye disorders	Ocular: Epithelium-on CXL Treatment Group	77	189	97
other	Corneal opacity	Eye disorders	Ocular: Sham Treatment/Control Group	11	90	11
other	Corneal opacity	Eye disorders	Non-ocular: Epithelium-on	0	118	0
other	Corneal opacity	Eye disorders	Non-ocular: Sham Treatment/Control	0	45	0
other	Corneal opacity	Eye disorders	Non-ocular: Epithelium-on and Sham Treatment	0	38	0

1 to 10 of 145Source ClinicalTrials.gov

See all 145 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ocular: Epithelium-on CXL Treatment Group	0	189
Total, all-cause mortality	Ocular: Sham Treatment/Control Group	0	90
Total, all-cause mortality	Non-ocular: Epithelium-on	0	118
Total, all-cause mortality	Non-ocular: Sham Treatment/Control	0	45
Total, all-cause mortality	Non-ocular: Epithelium-on and Sham Treatment	0	38
Total, other adverse events	Ocular: Epithelium-on CXL Treatment Group	170	189
Total, other adverse events	Ocular: Sham Treatment/Control Group	63	90
Total, other adverse events	Non-ocular: Epithelium-on	1	118
Total, other adverse events	Non-ocular: Sham Treatment/Control	0	45
Total, other adverse events	Non-ocular: Epithelium-on and Sham Treatment	2	38

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42640621	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03442751

GET https://conductscience.org/api/trials/v1/NCT03442751/events?page=2

API reference For AI assistants