Corneal Ulcer Clinical Trial
— MUTT IOfficial title:
Mycotic Ulcer Treatment Trial
Verified date | July 2018 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.
Status | Completed |
Enrollment | 323 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Presence of a corneal ulcer at presentation - Evidence of filamentous fungus on smear (KOH wet mount, Giemsa, or Gram stain) - Visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120 (20/400, logMAR 1.3) - 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 inpatient or to be treated as an outpatient and return every 3 days +/- 1 day until re-epithelialization and every week to receive fresh medication for 3 weeks - Appropriate consent Exclusion Criteria: - 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 (2/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment) - Acuity worse than 6/120 (20/400) or better than 6/12 (20/40) in the study eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA can be used for enrollment) - Known allergy to study medications (antifungal or preservative) - No light perception in the affected eye - Not willing to participate |
Country | Name | City | State |
---|---|---|---|
India | Aravind Eye Hospitals | Madurai | Tamil Nadu |
India | Aravind Eye Hospital | Pondicherry | Tamil Nadu |
United States | Proctor Foundation, UCSF | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Aravind Eye Hospitals, India, Dartmouth-Hitchcock Medical Center, National Eye Institute (NEI) |
United States, India,
Prajna NV, Krishnan T, Mascarenhas J, Rajaraman R, Prajna L, Srinivasan M, Raghavan A, Oldenburg CE, Ray KJ, Zegans ME, McLeod SD, Porco TC, Acharya NR, Lietman TM; Mycotic Ulcer Treatment Trial Group. The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole. JAMA Ophthalmol. 2013 Apr;131(4):422-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best Spectacle-corrected logMAR Visual Acuity | 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). | 3 months from enrollment | |
Secondary | Best Spectacle-corrected logMAR Visual Acuity | 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 | 3 weeks after enrollment | |
Secondary | Hard Contact Lens-corrected Visual Acuity Measured in logMAR | Hard contact lens-corrected visual acuity measured in logMAR (logarithm of the Minimum Angle of Resolution) 3 months after enrollment | 3 months after enrollment | |
Secondary | Size of Infiltrate/Scar | Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate | 3 weeks and 3 months after enrollment | |
Secondary | Time to 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. | From enrollment to the time of resolution of epithelial defect | |
Secondary | Minimum Inhibitory Concentration of Isolates | Minimum inhibitory concentration (50th percentile) of fungal isolates to natamycin and voriconazole | 3 months after enrollment | |
Secondary | Microbiological Cure at 6 Days | Microbiological cure defined as no fungal growth on culture at 6 (+/-1) days from enrollment | 7 days after enrollment |
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