MUTT_TE: Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT00557362
Collaborator
That Man May See, Inc. (Other), Aravind Eye Hospitals, India (Other), Dartmouth-Hitchcock Medical Center (Other)
120
Enrollment
2
Locations
4
Arms
9
Duration (Months)
60
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1/Phase 2

Detailed Description

Fungal ulcers tend to have very poor outcomes with the most common treatments, amphotericin B and natamycin. There has been only a single randomized trial of anti-fungal therapy for fungal ulcers and no new medications have been approved by the FDA since the 1960s. There are studies that indicate that the newer triazoles, such as voriconazole, are more effective in vitro against filamentous fungi such as Aspergillus spp., a common cause of fungal keratitis1-3. Despite a number of case reports and in vitro studies, there has been no systematic attempt to determine whether it is more or less effective clinically than natamycin, the only commercially available FDA-approved agent. There is little data available for physicians to make an informed, evidence-based decision on choice of antifungal.

We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data. The primary outcome is visual acuity at 3 months from enrollment. A subset of patients will be followed at 4 years from enrollment.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mycotic Ulcer Treatment Trial Therapeutic Exploratory Study
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: 1

Topical voriconazole with corneal de-epithelialization

Drug: Voriconazole
Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution. One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake

Procedure: Corneal de-epithelialization
Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Active Comparator: 2

Topical voriconazole without corneal de-epithelialization

Drug: Voriconazole
Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution. One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake

Active Comparator: 3

Topical natamycin with corneal de-epithelialization

Drug: Natamycin 5%
One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake

Procedure: Corneal de-epithelialization
Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Active Comparator: 4

Topical natamycin without corneal de-epithelialization

Drug: Natamycin 5%
One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake

Outcome Measures

Primary Outcome Measures

  1. Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model [3 months from enrollment]

    The primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.

Secondary Outcome Measures

  1. Time to Resolution of Epithelial Defect [3 months from enrollment]

    Resolution of epithelial defect was defined as the absence of an epithelial defect with administration of fluorescein. The time to re-epithelialization was compared between the voriconazole and natamycin groups using the Cox proportional hazards model, adjusting for baseline epithelial defect size.

  2. Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate. [3 months from enrollment]

    Size of infiltrate/scar post-treatment was analyzed in a linear regression model using enrollment infiltrate/scar size as a covariate. No differentiation was made between infiltrate and scar when measuring infiltrate/scar size (measured in mm). For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular.

  3. Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp). [3 months from enrollment]

    Two subgroup analyses were conducted by causative organism: 1) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Fusarium ulcers; 2) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Aspergillus ulcers.

  4. Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate [3 months from enrollment]

    Best hard contact lens-corrected visual acuity 3 months after enrollment was evaluated in a multiple linear regression model with enrollment hard contact lens-corrected visual acuity as a covariate. Visual acuity is reported in logMAR (logarithm of the Minimum Angle of Resolution).

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Presence of a corneal ulcer at presentation

  • Evidence of filamentous fungus on KOH (or Giemsa or any other stain) or culture

  • The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for follow-up visits.

  • Willingness to be treated as an in-patient or to be treated as an out-patient and come back every 48-72 hours to receive fresh medication for 3 weeks

  • Appropriate consent

Exclusion Criteria:
  • Overlying epithelial defect < 0.5 mm at its greatest width at presentation

  • Impending perforation

  • Evidence of bacteria on Gram stain at the time of enrollment

  • Evidence of acanthamoeba by stain

  • Evidence of herpetic keratitis by history or exam

  • Corneal scar not easily distinguishable from current ulcer

  • Age less than 16 years (before 16th birthday)

  • Bilateral ulcers

  • Previous penetrating keratoplasty in the affected eye

  • Pregnancy (by history or urine test) or breast-feeding (by history)

  • Acuity worse than 6/60 (20/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment)

  • Known allergy to study medications (antifungal or preservative)

  • No light perception in the affected eye

  • Not willing to participate

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Aravind Eye HospitalMaduraiTamil NaduIndia
2Aravind Eye HospitalPondicherryTamil NaduIndia

Sponsors and Collaborators

  • University of California, San Francisco
  • That Man May See, Inc.
  • Aravind Eye Hospitals, India
  • Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Thomas M Lietman, MD, Proctor Foundation, University of California, San Francisco
  • Principal Investigator: Nisha Acharya, MD MS, Proctor Foundation, University of California, San Francisco
  • Study Director: N V Prajna, MD, Aravind Eye Hospital, India

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00557362
Other Study ID Numbers:
  • H9332-31301-01
First Posted:
Nov 14, 2007
Last Update Posted:
Aug 7, 2018
Last Verified:
Jul 1, 2018

Study Results

Participant Flow

Recruitment DetailsFrom November 27, 2007 to May 12, 2008, all patients with a corneal ulcer presenting to Aravind Eye Hospital's cornea clinics in Madurai and Pondicherry, India, were evaluated for eligibility. The Aravind Eye Care System is both a primary and tertiary care eye hospital in South India with a well-established cornea subspecialty clinic.
Pre-assignment DetailAll patients with a corneal ulcer had corneal scrapings using a Kimura spatula for Gram stain and potassium hydroxide wet mount and had cultures plated on blood, chocolate, and potato dextrose agar. If all inclusion criteria and no exclusion criteria were met, the patient was enrolled in the study.
Arm/Group TitleTopical Natamycin With Corneal De-epithelializationTopical Natamycin Without Corneal De-epithelializationTopical Voriconazole With Corneal De-epithelializationTopical Voriconazole Without Corneal De-epithelialization
Arm/Group DescriptionTopical natamycin with corneal de-epithelialization. Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.Topical natamycin without corneal de-epithelialization. Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Topical voriconazole with corneal de-epithelialization. Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.Topical voriconazole without corneal de-epithelialization. Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Period Title: Overall Study
STARTED30303030
COMPLETED28282627
NOT COMPLETED2243

Baseline Characteristics

Arm/Group TitleTopical Voriconazole With Corneal De-epithelializationTopical Voriconazole Without Corneal De-epithelializationTopical Natamycin With Corneal De-epithelializationTopical Natamycin Without Corneal De-epithelializationTotal
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Total of all reporting groups
Overall Participants30303030120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
47.0
(14.5)
45.0
(14.5)
49.8
(11.9)
45.9
(13.1)
46.93
(13.72)
Sex: Female, Male (Count of Participants)
Female
14
46.7%
9
30%
7
23.3%
11
36.7%
41
34.2%
Male
16
53.3%
21
70%
23
76.7%
19
63.3%
79
65.8%
Region of Enrollment (participants) [Number]
India
30
100%
30
100%
30
100%
30
100%
120
100%
Enrollment logMAR BSCVA (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]
0.94
(0.66)
0.96
(0.66)
0.87
(0.67)
0.94
(0.61)
0.93
(0.64)

Outcome Measures

1. Primary Outcome
TitleBest Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model
DescriptionThe primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.
Time Frame3 months from enrollment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTopical VoriconazoleTopical Natamycin
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Measure Participants6060
Mean (95% Confidence Interval) [logMAR]
0.61
0.71
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Voriconazole, Topical Natamycin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.29
Comments
MethodRegression, Linear
CommentsMultiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value-0.098
Confidence Interval (2-Sided) 95%
-0.28 to 0.083
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
TitleTime to Resolution of Epithelial Defect
DescriptionResolution of epithelial defect was defined as the absence of an epithelial defect with administration of fluorescein. The time to re-epithelialization was compared between the voriconazole and natamycin groups using the Cox proportional hazards model, adjusting for baseline epithelial defect size.
Time Frame3 months from enrollment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTopical VoriconazoleTopical Natamycin
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awakeDrug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake
Measure Participants6060
Mean (Standard Deviation) [days]
13.07
(7.71)
15.2
(7.03)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Voriconazole, Topical Natamycin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.40
Comments
MethodRegression, Cox
Comments
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value1.23
Confidence Interval (2-Sided) 95%
0.76 to 2.02
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
TitleSize of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.
DescriptionSize of infiltrate/scar post-treatment was analyzed in a linear regression model using enrollment infiltrate/scar size as a covariate. No differentiation was made between infiltrate and scar when measuring infiltrate/scar size (measured in mm). For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular.
Time Frame3 months from enrollment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTopical VoriconazoleTopical Natamycin
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Note that 9 patients in the voriconazole arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Note that 5 patients in the natamycin arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses.
Measure Participants5155
Mean (95% Confidence Interval) [mm]
4.21
4.08
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Voriconazole, Topical Natamycin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.37
Comments
MethodRegression, Linear
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value0.17
Confidence Interval (2-Sided) 95%
-0.20 to 0.53
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
TitleSubgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).
DescriptionTwo subgroup analyses were conducted by causative organism: 1) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Fusarium ulcers; 2) best spectacle-corrected visual acuity (BSCVA) by treatment arm among Aspergillus ulcers.
Time Frame3 months from enrollment

Outcome Measure Data

Analysis Population Description
This analysis looks at two different subgroups - Fusarium ulcers and Aspergillus ulcers. There were 44 Fusaruim ulcers enrolled in this trial and analyzed here, 23 of which were randomized to voriconazole and 21 to natamycin. There were 19 Aspergillus ulcers analyzed here, 8 of which were randomized to voriconazole and 11 to natamycin.
Arm/Group TitleTopical VoriconazoleTopical Natamycin
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Measure Participants3132
BSCVA Fusarium ulcers (n=23 vori; n=21 nata)
0.58
0.50
BSCVA Aspergillus ulcers (n=8 vori; n=11 nata)
0.48
0.68
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Voriconazole, Topical Natamycin
Comments Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.62
Comments
MethodRegression, Linear
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value0.08
Confidence Interval (2-Sided) 95%
-0.25 to 0.41
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Topical Voriconazole, Topical Natamycin
Comments Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.26
Comments
MethodRegression, Linear
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value-0.20
Confidence Interval (2-Sided) 95%
-0.57 to 0.17
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
TitleBest Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate
DescriptionBest hard contact lens-corrected visual acuity 3 months after enrollment was evaluated in a multiple linear regression model with enrollment hard contact lens-corrected visual acuity as a covariate. Visual acuity is reported in logMAR (logarithm of the Minimum Angle of Resolution).
Time Frame3 months from enrollment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleTopical VoriconazoleTopical Natamycin
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Measure Participants3840
Mean (95% Confidence Interval) [logMAR]
0.39
0.46
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Topical Voriconazole, Topical Natamycin
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesisp-Value0.53
Comments
MethodRegression, Linear
Comments
Method of EstimationEstimation ParameterMean Difference (Net)
Estimated Value-0.06
Confidence Interval (2-Sided) 95%
-0.26 to 0.14
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group TitleTopical Voriconazole With Corneal De-epithelializationTopical Voriconazole Without Corneal De-epithelializationTopical Natamycin With Corneal De-epithelializationTopical Natamycin Without Corneal De-epithelialization
Arm/Group DescriptionDrug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake. Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
All Cause Mortality
Topical Voriconazole With Corneal De-epithelializationTopical Voriconazole Without Corneal De-epithelializationTopical Natamycin With Corneal De-epithelializationTopical Natamycin Without Corneal De-epithelialization
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Topical Voriconazole With Corneal De-epithelializationTopical Voriconazole Without Corneal De-epithelializationTopical Natamycin With Corneal De-epithelializationTopical Natamycin Without Corneal De-epithelialization
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/30 (20%) 5/30 (16.7%) 8/30 (26.7%) 1/30 (3.3%)
Eye disorders
Corneal perforation5/30 (16.7%) 55/30 (16.7%) 58/30 (26.7%) 81/30 (3.3%) 1
General disorders
Death1/30 (3.3%) 10/30 (0%) 00/30 (0%) 00/30 (0%) 0
Other (Not Including Serious) Adverse Events
Topical Voriconazole With Corneal De-epithelializationTopical Voriconazole Without Corneal De-epithelializationTopical Natamycin With Corneal De-epithelializationTopical Natamycin Without Corneal De-epithelialization
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/30 (6.7%) 5/30 (16.7%) 2/30 (6.7%) 2/30 (6.7%)
Eye disorders
Local allergic reaction0/30 (0%) 01/30 (3.3%) 10/30 (0%) 00/30 (0%) 0
Increase in hypopyon0/30 (0%) 02/30 (6.7%) 20/30 (0%) 01/30 (3.3%) 1
Increase in infiltrate1/30 (3.3%) 11/30 (3.3%) 11/30 (3.3%) 11/30 (3.3%) 1
No resolution of epithelial defect by 21 days0/30 (0%) 00/30 (0%) 01/30 (3.3%) 10/30 (0%) 0
Progressive corneal thinning1/30 (3.3%) 11/30 (3.3%) 10/30 (0%) 00/30 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleTom M/ Lietman
OrganizationUniversity of California San Francisco Proctor Foundation
Phone4155022662
Emailtom.lietman@ucsf.edu
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00557362
Other Study ID Numbers:
  • H9332-31301-01
First Posted:
Nov 14, 2007
Last Update Posted:
Aug 7, 2018
Last Verified:
Jul 1, 2018