Trial · NCT00996736
Mycotic Ulcer Treatment Trial I
NCT00996736, Phase 3, Completed, University of California, San Francisco; results first posted 2013-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mycotic Ulcer Treatment Trial I. Trials, record NCT00996736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00996736
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mycotic Ulcer Treatment Trial I
- NCT number
- NCT00996736
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 323 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Corneal Ulcer, Eye Infections, Fungal
- Interventions
- Natamycin, Voriconazole
- First posted
- 2009-10-16
- Last updated
- 2018-08-01
- Results first posted
- 2013-12-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Spectacle-corrected logMAR Visual Acuity | 3 months from enrollment | The primary analysis is best spectacle-corrected logMAR (logarithm of the Minimum Angle or Resolution) visual acuity, correcting for enrollment BSCVA and treatment arm in a multiple linear regression model. The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis). |
| Secondary | Best Spectacle-corrected logMAR Visual Acuity | 3 weeks after enrollment | Best spectacle-corrected logMAR (logarithm of the Minimum Angle of Resolution) visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model |
| Secondary | Hard Contact Lens-corrected Visual Acuity Measured in logMAR | 3 months after enrollment | Hard contact lens-corrected visual acuity measured in logMAR (logarithm of the Minimum Angle of Resolution) 3 months after enrollment |
| Secondary | Size of Infiltrate/Scar | 3 weeks and 3 months after enrollment | Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate |
| Secondary | Time to Resolution of Epithelial Defect | From enrollment to the time of resolution of epithelial defect | Time in days from enrollment to resolution of epithelial defect. For those subjects with more than 21 days to resolution, 21 days was used. |
| Secondary | Minimum Inhibitory Concentration of Isolates | 3 months after enrollment | Minimum inhibitory concentration (50th percentile) of fungal isolates to natamycin and voriconazole |
| Secondary | Microbiological Cure at 6 Days | 7 days after enrollment | Microbiological cure defined as no fungal growth on culture at 6 (+/-1) days from enrollment |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Spectacle-corrected logMAR Visual Acuity | 3 months from enrollment | logMAR | MEAN | |
| SECONDARY | Best Spectacle-corrected logMAR Visual Acuity | 3 weeks after enrollment | 306 total subjects (155 in natamycin arm, 151 in voriconazole arm) returned after enrollment for a second visit, but only 293 of those (149 in natamycin arm and 144 in voriconazole arm) visited within the 3-week window (2.5-5 weeks). Only those who visited within the window were included in the analysis. | logMAR | MEAN |
| SECONDARY | Hard Contact Lens-corrected Visual Acuity Measured in logMAR | 3 months after enrollment | logMAR | MEAN | |
| SECONDARY | Size of Infiltrate/Scar | 3 weeks and 3 months after enrollment | mm | MEAN | |
| SECONDARY | Time to Resolution of Epithelial Defect | From enrollment to the time of resolution of epithelial defect | days | MEAN | |
| SECONDARY | Minimum Inhibitory Concentration of Isolates | 3 months after enrollment | The population for analysis included only those subjects with positive fungal cultures and for whom Minimum Inhibitory Concentrations were available (108 subjects who were randomized to natamycin and 113 who were randomized to voriconazole). | μg/ml | MEAN |
| SECONDARY | Microbiological Cure at 6 Days | 7 days after enrollment | Of the 323 participants with smear-positive ulcers enrolled in the trial, 299 (92.6%) were scraped and cultured 6 days after enrollment - 155 in the natamycin arm, and 144 in the voriconazole arm. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Spectacle-corrected logMAR Visual Acuity | Topical Natamycin | 0.39 | 95% Confidence Interval 0.30 to 0.48 | logMAR | |
| Best Spectacle-corrected logMAR Visual Acuity | Topical Voriconazole | 0.57 | 95% Confidence Interval 0.48 to 0.65 | logMAR | |
| Best Spectacle-corrected logMAR Visual Acuity | Topical Natamycin | 0.49 | 95% Confidence Interval 0.42 to 0.57 | logMAR | |
| Best Spectacle-corrected logMAR Visual Acuity | Topical Voriconazole | 0.63 | 95% Confidence Interval 0.56 to 0.70 | logMAR | |
| Hard Contact Lens-corrected Visual Acuity Measured in logMAR | Topical Natamycin | 0.18 | 95% Confidence Interval 0.11 to 0.26 | logMAR | |
| Hard Contact Lens-corrected Visual Acuity Measured in logMAR | Topical Voriconazole | 0.30 | 95% Confidence Interval 0.22 to 0.38 | logMAR | |
| Size of Infiltrate/Scar | Topical Natamycin | 3 weeks from enrollment | 3.30 | 95% Confidence Interval 3.15 to 3.48 | mm |
| Size of Infiltrate/Scar | Topical Voriconazole | 3 weeks from enrollment | 3.44 | 95% Confidence Interval 3.29 to 3.60 | mm |
| Size of Infiltrate/Scar | Topical Natamycin | 3 months from enrollment | 3.31 | 95% Confidence Interval 3.15 to 3.48 | mm |
| Size of Infiltrate/Scar | Topical Voriconazole | 3 months from enrollment | 3.52 | 95% Confidence Interval 3.35 to 3.68 | mm |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topical Natamycin | 162 | |
| Overall Study | STARTED | Topical Voriconazole | 161 | |
| Overall Study | 3-week Visit | Topical Natamycin | 155 | |
| Overall Study | 3-week Visit | Topical Voriconazole | 151 | |
| Overall Study | 3-month Visit | Topical Natamycin | 146 | |
| Overall Study | 3-month Visit | Topical Voriconazole | 146 | |
| Overall Study | COMPLETED | Topical Natamycin | 141 | |
| Overall Study | COMPLETED | Topical Voriconazole | 143 | |
| Overall Study | NOT COMPLETED | Topical Natamycin | 21 | |
| Overall Study | NOT COMPLETED | Topical Voriconazole | 18 |
Source ClinicalTrials.gov
Adverse events18
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 | Increase in hypopyon (>2mm) | Eye disorders | Topical Natamycin | 5 | 162 | |
| other | Increase in hypopyon (>2mm) | Eye disorders | Topical Voriconazole | 12 | 161 | |
| other | Increase in infiltrate size > 50% | Eye disorders | Topical Natamycin | 5 | 162 | |
| other | Increase in infiltrate size > 50% | Eye disorders | Topical Voriconazole | 13 | 161 | |
| other | Progressive corneal thinning, <=50% of enrollment thickness | Eye disorders | Topical Natamycin | 0 | 162 | |
| other | Progressive corneal thinning, <=50% of enrollment thickness | Eye disorders | Topical Voriconazole | 2 | 161 | |
| serious | Corneal perforation | Eye disorders | Topical Natamycin | 10 | 162 | |
| serious | Corneal perforation | Eye disorders | Topical Voriconazole | 15 | 161 | |
| serious | Therapeutic penetrating keratoplasty | Eye disorders | Topical Natamycin | 13 | 162 | |
| serious | Therapeutic penetrating keratoplasty | Eye disorders | Topical Voriconazole | 29 | 161 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topical Natamycin | ||
| Total, all-cause mortality | Topical Voriconazole | ||
| Total, other adverse events | Topical Natamycin | 10 | 162 |
| Total, other adverse events | Topical Voriconazole | 27 | 161 |
| Total, serious adverse events | Topical Natamycin | 42 | 162 |
| Total, serious adverse events | Topical Voriconazole | 82 | 161 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY018573 | Myocotic Ulcer Treatment Trial | LIETMAN, THOMAS M | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL EYE INSTITUTE | 2009 to 2014 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topical Natamycin vs Topical Voriconazole: Microbiological Cure at 6 Days | Trial comparisons |
| Topical Natamycin vs Topical Voriconazole: 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.
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/NCT00996736
GET https://conductscience.org/api/trials/v1/NCT00996736/registered