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

2014-08-27 03:35:10 | BioPortfolio

Summary

We are planning to evaluate whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. The study being proposed in this application is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.

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 are planning to evaluate whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. The study being proposed in this application is a therapeutic exploratory study to investigate the safety and feasibility of conducting the main study and to generate preliminary data.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Fungal Keratitis

Intervention

Natamycin 5%, Voriconazole, Corneal de-epithelialization

Location

Aravind Eye Hospital
Madurai
Tamil Nadu
India

Status

Completed

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:35:10-0400

Clinical Trials [494 Associated Clinical Trials listed on BioPortfolio]

Combination Treatment of 5% Natamycin and 1% Voriconazole in Fungal Keratitis

OBJECTIVE To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and 1% Voriconazole in patients affected by fungal keratitis METHODS AND MATERIALS STUDY POPULATIO...

Mycotic Ulcer Treatment Trial I

The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.

Microbiological Diagnosis of Infectious Keratitis to Pathogenic Fastidious Germs

Infectious keratitis are favored by the circumstances causing the small trauma of the corneal epithelium, corneal surgery, corneal dryness under health system such as Sjögren's syndrome r...

UVX as an Adjuvant in the Treatment of Fungal Keratitis

In this study, investigators want to find the effect of adjuvant collagen cross-linking in the treatment of fungal keratitis

Mycotic Ulcer Treatment Trial II

The purpose of this study is to determine if the addition of oral voriconazole to topical treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.

PubMed Articles [1594 Associated PubMed Articles listed on BioPortfolio]

Periocular contact dermatitis with use of topical voriconazole 1% in mycotic keratitis.

We present two cases of culture-proven fungal keratitis on natamycin treatment which developed periocular erythema, oedema, burning sensation and pruritus within 48 hours of the addition of topical ...

Impact of Iontophoresis and PACK-CXL Corneal Concentrations of Antifungals in an In Vivo Model.

To investigate voriconazole (VRZ) penetration and fungal load in the cornea after applying VRZ therapy with various treatment combinations in a fungal keratitis model.

Effectiveness of voriconazole and corneal cross-linking on Phialophora verrucosa keratitis: a case report.

We report a rare case of Phialophora verrucosa fungal keratitis, which required various types of treatment according to the intractable natural history of the disease.

Two-photon microscopy of fungal keratitis-affected rabbit cornea ex vivo using moxifloxacin as a labeling agent.

Two-photon microscopy (TPM) is a three dimensional (3D) microscopic technique based on nonlinear two-photon fluorescence, which has been tested as an alternative to reflectance confocal microscopy (RC...

Therapeutic Penetrating Keratoplasty Button Cultures in The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo.

To compare oral voriconazole versus placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis.

Medical and Biotech [MESH] Definitions

New blood vessels originating from the corneal veins and extending from the limbus into the adjacent CORNEAL STROMA. Neovascularization in the superficial and/or deep corneal stroma is a sequel to numerous inflammatory diseases of the ocular anterior segment, such as TRACHOMA, viral interstitial KERATITIS, microbial KERATOCONJUNCTIVITIS, and the immune response elicited by CORNEAL TRANSPLANTATION.

Amphoteric macrolide antifungal antibiotic from Streptomyces natalensis or S. chattanoogensis. It is used for a variety of fungal infections, mainly topically.

Corneal and conjunctival dryness due to deficient tear production, predominantly in menopausal and post-menopausal women. Filamentary keratitis or erosion of the conjunctival and corneal epithelium may be caused by these disorders. Sensation of the presence of a foreign body in the eye and burning of the eyes may occur.

Infection of the cornea by an ameboid protozoan which may cause corneal ulceration leading to blindness.

A mitosporic fungal genus occasionally causing human diseases such as pulmonary infections, mycotic keratitis, endocarditis, and opportunistic infections. Its teleomorph is BYSSOCHLAMYS.

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