Trial · NCT02570321

Cross-linking for Corneal Ulcers Treatment Trial

NCT02570321, Phase 3, Completed, University of California, San Francisco; results first posted 2024-08-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cross-linking for Corneal Ulcers Treatment Trial. Trials, record NCT02570321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02570321

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Trial

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

Title: Cross-linking for Corneal Ulcers Treatment Trial
NCT number: NCT02570321
Status: Completed
Phases: Phase 3
Enrollment: 147 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Corneal Ulcer, Infectious Keratitis, Bacterial Ulcer, Fungal Ulcer
Interventions: Corneal Cross-linking, Anti Fungal Drug
First posted: 2015-10-07
Last updated: 2025-06-18
Results first posted: 2024-08-27

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Microbiological Cure on Repeat Culture	4 to 24 hours after enrollment	Corneal scraping of the ulcer will be performed and directly inoculated on to sheep's blood agar, chocolate agar, potato dextrose agar or Sabouraud's agar for bacterial and fungal culture. Microbiological cure is defined as no growth of bacteria or fungus on these media.
Secondary	Best Spectacle-corrected Visual Acuity	3 months	Best corrected visual acuity will be measured at baseline for both eyes using the standard ETDRS chart light box at the 4- and 1-meter test distances. In the case that the patient reads less than 10 letters at 4 meters, move the patient or the chart to a distance of 1 meter from the patient.
Secondary	Scar Size	3 months	Study clinician will measure infiltrate or scar size using a standardized protocol with the slit lamp biomicroscope. The geometric mean of the scar size will be measured by recording the horizontal and vertical diameter.
Secondary	Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty	3 months	Adverse events include glaucoma, endophthalmitis, medication reaction, perforation including treatment by therapeutic penetrating keratoplasty.
Other	Vision Related Quality of Life	3 months	Mobility subscale: As measured by the Indian Visual Function Questionnaire (IVFQ) which records quality of life on a scale of 0 to 100 with 100 representing the best quality of life.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Microbiological Cure on Repeat Culture	4 to 24 hours after enrollment		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Best Spectacle-corrected Visual Acuity	3 months		logMar	MEDIAN
SECONDARY	Scar Size	3 months		mm	MEAN
SECONDARY	Adverse Events Including Rate of Perforation/Need for Therapeutic Penetrating Keratoplasty	3 months		participants	NUMBER
OTHER_PRE_SPECIFIED	Vision Related Quality of Life	3 months	These data were exploratory in nature, we did not collect the data.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group52

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

Outcome	Group	Category	Value	Units
Microbiological Cure on Repeat Culture	Bacterial Ulcer Control	Culture negative	5	Participants
Microbiological Cure on Repeat Culture	Bacterial Ulcer Cross-linking	Culture negative	5	Participants
Microbiological Cure on Repeat Culture	Fungal Ulcer Control With Natamycin	Culture negative	17	Participants
Microbiological Cure on Repeat Culture	Fungal Ulcer Cross-linking Plus Natamycin	Culture negative	14	Participants
Microbiological Cure on Repeat Culture	Fungal Ulcer Control With Amphotericin	Culture negative	15	Participants
Microbiological Cure on Repeat Culture	Fungal Ulcer Cross-linking Plus Amphotericin	Culture negative	13	Participants
Microbiological Cure on Repeat Culture	Bacterial Ulcer Control	Culture positive	14	Participants
Microbiological Cure on Repeat Culture	Bacterial Ulcer Cross-linking	Culture positive	11	Participants
Microbiological Cure on Repeat Culture	Fungal Ulcer Control With Natamycin	Culture positive	9	Participants
Microbiological Cure on Repeat Culture	Fungal Ulcer Cross-linking Plus Natamycin	Culture positive	12	Participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Bacterial Ulcer Control	19
Overall Study	STARTED	Bacterial Ulcer Cross-linking	17
Overall Study	STARTED	Fungal Ulcer Control With Natamycin	26
Overall Study	STARTED	Fungal Ulcer Cross-linking Plus Natamycin	27
Overall Study	STARTED	Fungal Ulcer Control With Amphotericin	30
Overall Study	STARTED	Fungal Ulcer Cross-linking Plus Amphotericin	28
Overall Study	COMPLETED	Bacterial Ulcer Control	17
Overall Study	COMPLETED	Bacterial Ulcer Cross-linking	16
Overall Study	COMPLETED	Fungal Ulcer Control With Natamycin	21
Overall Study	COMPLETED	Fungal Ulcer Cross-linking Plus Natamycin	27

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events24

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
other	Median tarsorrhaphy	Eye disorders	Bacterial Ulcer Control	0	19
other	Median tarsorrhaphy	Eye disorders	Bacterial Ulcer Cross-linking	0	17
other	Median tarsorrhaphy	Eye disorders	Fungal Ulcer Control With Natamycin	0	26
other	Median tarsorrhaphy	Eye disorders	Fungal Ulcer Cross-linking Plus Natamycin	0	27
other	Median tarsorrhaphy	Eye disorders	Fungal Ulcer Control With Amphotericin	0	30
other	Median tarsorrhaphy	Eye disorders	Fungal Ulcer Cross-linking Plus Amphotericin	1	28
serious	Perforation	Eye disorders	Bacterial Ulcer Control	1	19
serious	Perforation	Eye disorders	Bacterial Ulcer Cross-linking	0	17
serious	Perforation	Eye disorders	Fungal Ulcer Control With Natamycin	2	26
serious	Perforation	Eye disorders	Fungal Ulcer Cross-linking Plus Natamycin	1	27

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Bacterial Ulcer Control	19
Total, all-cause mortality	Bacterial Ulcer Cross-linking	17
Total, all-cause mortality	Fungal Ulcer Control With Natamycin	26
Total, all-cause mortality	Fungal Ulcer Cross-linking Plus Natamycin	27
Total, all-cause mortality	Fungal Ulcer Control With Amphotericin	30
Total, all-cause mortality	Fungal Ulcer Cross-linking Plus Amphotericin	28
Total, other adverse events	Bacterial Ulcer Control	19
Total, other adverse events	Bacterial Ulcer Cross-linking	17
Total, other adverse events	Fungal Ulcer Control With Natamycin	26
Total, other adverse events	Fungal Ulcer Cross-linking Plus Natamycin	27

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31619359	DERIVED	PubMed
32557558	DERIVED	PubMed
33031809	DERIVED	PubMed
33079921	DERIVED	PubMed
35024776	DERIVED	PubMed
35044972	DERIVED	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.

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