Trial · NCT00647699

Corneal Collagen Cross-linking for Progressive Keratoconus

NCT00647699, Phase 3, Completed, Glaukos Corporation; results first posted 2016-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Corneal Collagen Cross-linking for Progressive Keratoconus. Trials, record NCT00647699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00647699

On this page

Trial

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

Title: Corneal Collagen Cross-linking for Progressive Keratoconus
NCT number: NCT00647699
Status: Completed
Phases: Phase 3
Enrollment: 147 participants, actual
Lead sponsor: Glaukos Corporation
Conditions: Progressive Keratoconus
Interventions: riboflavin ophthalmic solution, UVA Irradiation
First posted: 2008-04-01
Last updated: 2021-04-26
Results first posted: 2016-07-07

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Maximum Keratometry (Kmax)	baseline,12 months	The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Maximum Keratometry (Kmax)	baseline,12 months	The ITT (intent to treat) population consisted of all treated subjects, analyzed according to the treatment actually received. For the sham study eyes that received CXL treatment after baseline, the last Kmax measurement recorded prior to receiving CXL treatment was used in the analysis for later time points.	diopters	MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Maximum Keratometry (Kmax)	Corneal Collagen Cross-linking (CXL) Treatment Group		-1.7	Standard Deviation 4.7	diopters
Mean Change From Baseline in Maximum Keratometry (Kmax)	Control Group		0.6	Standard Deviation 2.8	diopters

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Corneal Collagen Cross-linking (CXL) Treatment Group	73
Overall Study	STARTED	Control Group	74
Overall Study	COMPLETED	Corneal Collagen Cross-linking (CXL) Treatment Group	65
Overall Study	COMPLETED	Control Group	62
Overall Study	NOT COMPLETED	Corneal Collagen Cross-linking (CXL) Treatment Group	8
Overall Study	NOT COMPLETED	Control Group	12

Source ClinicalTrials.gov

Adverse events54

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	Corneal opacity	Eye disorders	Corneal Collagen Cross-linking (CXL) Treatment Group	35	73	43
other	Corneal opacity	Eye disorders	Control Group	1	74	1
other	Eye pain	Eye disorders	Corneal Collagen Cross-linking (CXL) Treatment Group	13	73	13
other	Eye pain	Eye disorders	Control Group	3	74	3
other	Punctate keratitis	Eye disorders	Corneal Collagen Cross-linking (CXL) Treatment Group	13	73	16
other	Punctate keratitis	Eye disorders	Control Group	8	74	8
other	Corneal striae	Eye disorders	Corneal Collagen Cross-linking (CXL) Treatment Group	11	73	11
other	Corneal striae	Eye disorders	Control Group	5	74	5
other	Corneal epithelial defect	Eye disorders	Corneal Collagen Cross-linking (CXL) Treatment Group	10	73	11
other	Corneal epithelial defect	Eye disorders	Control Group	1	74	1

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Corneal Collagen Cross-linking (CXL) Treatment Group
Total, all-cause mortality	Control Group
Total, other adverse events	Corneal Collagen Cross-linking (CXL) Treatment Group	57	73
Total, other adverse events	Control Group	25	74
Total, serious adverse events	Corneal Collagen Cross-linking (CXL) Treatment Group	0	73
Total, serious adverse events	Control Group	3	74

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22692521	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 comparisons1

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

Comparison
Corneal Collagen Cross-linking (CXL) Treatment Group vs Control Group: serious adverse events

Source Trial comparisons

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/NCT00647699

GET https://conductscience.org/api/trials/v1/NCT00647699/events?page=2

API reference For AI assistants