Trial · NCT02731638

Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers

NCT02731638, Phase 3, Completed, University of California, San Francisco; results first posted 2019-10-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers. Trials, record NCT02731638. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02731638

On this page

Trial

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

Title: Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
NCT number: NCT02731638
Status: Completed
Phases: Phase 3
Enrollment: 70 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Corneal Ulcer, Fungal Keratitis
Interventions: Intrastromal voriconazole, Natamycin
First posted: 2016-04-07
Last updated: 2025-09-25
Results first posted: 2019-10-01

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus	3 days	Number of of participants with positive fungal cultures at 3 days
Secondary	Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist	3 weeks and 3 months	Best spectacle-corrected visual acuity using calibrated Original Series Early Treatment Diabetic Retinopathy Study eye charts and recorded as number of letter read.
Secondary	Scar Size	3 weeks and 3 months	Scar size, geometric mean
Secondary	Number of Participants With Scar Depth at the Anterior Third, Middle Third, and Posterior Third of the Cornea	3 weeks and 3 months	Number of participants with scar depth at the anterior third (0-33% depth), middle third (\>33-67% depth), and posterior third (\>67-100% depth) of the cornea, as measured on slit lamp exam.
Other	Corneal Neovascularization	3 months	As measured by clinical examination and slit lamp photographs.
Other	Change in Quality of Life, Measured by the Indian Vision Function Questionnaire (IND-VFQ)	3 months
Other	Corneal Thinning, as Measured by Pachymetry and OCT	6 months
Other	Corneal Topography, as Measured by a Non-contact Imaging Topographer	6 months

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus	3 days	3-day culture results missing for one participant in the Natamycin group	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist	3 weeks and 3 months	3-week visual acuity data was available for 65 people: 33 in the ISV group (2 lost to follow-up) and 32 in the Natamycin only group (3 lost of follow-up). 3-month visual acuity data was available for 58 people: 30 in the ISV group (5 lost to follow-up) and 28 in the Natamycin only group (7 lost to follow-up).	logarithm of the minimum angle (logMAR)	MEAN
SECONDARY	Scar Size	3 weeks and 3 months	3-week scar size data was available for 42 people: 24 in the ISV group (2 lost to follow-up \[LTF\], 9 unable to assess) and 18 in the Natamycin only group (3 LTF, 14 unable to assess). 3-month scar size data was available for 29 people: 16 in the ISV group (5 LTF, 14 unable to assess) and 13 in the Natamycin only group (7 LTF, 15 unable to assess).	millimeters squared	MEAN
SECONDARY	Number of Participants With Scar Depth at the Anterior Third, Middle Third, and Posterior Third of the Cornea	3 weeks and 3 months	3-week scar depth data was available for 40 people: 24 in the ISV group (2 lost to follow-up \[LTF\], 9 unable to assess) and 16 in the Natamycin only group (3 LTF, 16 unable to assess). 3-month scar depth was available for 29 people: 16 in the ISV group (5 LTF, 14 unable to assess) and 13 in the Natamycin only group (7 LTF, 15 unable to assess).	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Corneal Neovascularization	3 months
OTHER_PRE_SPECIFIED	Change in Quality of Life, Measured by the Indian Vision Function Questionnaire (IND-VFQ)	3 months
OTHER_PRE_SPECIFIED	Corneal Thinning, as Measured by Pachymetry and OCT	6 months
OTHER_PRE_SPECIFIED	Corneal Topography, as Measured by a Non-contact Imaging Topographer	6 months

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Spread	Units
Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus	Intrastromal Voriconazole Plus Natamycin		14		Participants
Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus	Natamycin Alone		11		Participants
Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist	Intrastromal Voriconazole Plus Natamycin	3 weeks	1.39	Standard Deviation 0.59	logarithm of the minimum angle (logMAR)
Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist	Natamycin Alone	3 weeks	1.23	Standard Deviation 0.65	logarithm of the minimum angle (logMAR)
Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist	Intrastromal Voriconazole Plus Natamycin	3 months	1.30	Standard Deviation 0.60	logarithm of the minimum angle (logMAR)
Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist	Natamycin Alone	3 months	1.28	Standard Deviation 0.66	logarithm of the minimum angle (logMAR)
Scar Size	Intrastromal Voriconazole Plus Natamycin	3 Weeks	4.8	Standard Deviation 1.2	millimeters squared
Scar Size	Natamycin Alone	3 Weeks	4.1	Standard Deviation 1.3	millimeters squared
Scar Size	Intrastromal Voriconazole Plus Natamycin	3 Months	4.9	Standard Deviation 1.2	millimeters squared
Scar Size	Natamycin Alone	3 Months	4.5	Standard Deviation 1.1	millimeters squared

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intrastromal Voriconazole Plus Natamycin	35
Overall Study	STARTED	Natamycin Alone	35
Overall Study	COMPLETED	Intrastromal Voriconazole Plus Natamycin	29
Overall Study	COMPLETED	Natamycin Alone	26
Overall Study	NOT COMPLETED	Intrastromal Voriconazole Plus Natamycin	6
Overall Study	NOT COMPLETED	Natamycin Alone	9

Source ClinicalTrials.gov

Adverse events16

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	Endophthalmitis	Eye disorders	Intrastromal Voriconazole Plus Natamycin	0	35
other	Endophthalmitis	Eye disorders	Natamycin Alone	2	35
other	Glaucoma	Eye disorders	Intrastromal Voriconazole Plus Natamycin	4	35
other	Glaucoma	Eye disorders	Natamycin Alone	2	35
other	Hypopyon	Eye disorders	Intrastromal Voriconazole Plus Natamycin	3	35
other	Hypopyon	Eye disorders	Natamycin Alone	0	35
other	Medication Reaction	Eye disorders	Intrastromal Voriconazole Plus Natamycin	0	35
other	Medication Reaction	Eye disorders	Natamycin Alone	1	35
other	Nonhealing Ulcer	Eye disorders	Intrastromal Voriconazole Plus Natamycin	3	35
other	Nonhealing Ulcer	Eye disorders	Natamycin Alone	0	35

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intrastromal Voriconazole Plus Natamycin	0	35
Total, all-cause mortality	Natamycin Alone	0	35
Total, other adverse events	Intrastromal Voriconazole Plus Natamycin	16	35
Total, other adverse events	Natamycin Alone	15	35
Total, serious adverse events	Intrastromal Voriconazole Plus Natamycin	0	35
Total, serious adverse events	Natamycin Alone	0	35

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
Intrastromal Voriconazole Plus Natamycin vs Natamycin Alone: Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus	Trial comparisons
Intrastromal Voriconazole Plus Natamycin vs Natamycin Alone: deaths from any cause	Trial comparisons
Intrastromal Voriconazole Plus Natamycin vs Natamycin Alone: serious adverse events	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/NCT02731638

GET https://conductscience.org/api/trials/v1/NCT02731638/results?page=2

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