Mycotic Ulcer Treatment Trial II

2014-07-23 21:12:26 | BioPortfolio


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.


Fungal corneal ulcers tend to have very poor outcomes with commonly used treatments. There has only been a single randomized trial of anti-fungal therapy for mycotic keratitis, and no new ocular anti-fungal medications have been approved by the FDA since the 1960s. The triazole voriconazole has recently become the treatment of choice for systemic fungal infections such as pulmonary aspergillosis. The use of topical ophthalmic preparations of voriconazole has been described in numerous case reports, however there has been no systematic attempt to determine whether it is more or less clinically effective than natamycin. Additionally, there have been many case reports of the use of oral voriconazole in the treatment of fungal corneal ulcers, however there has been no systematic attempt to determine if it improves outcomes in severe ulcers.

This study is a randomized, double-masked, placebo-controlled trial to determine if the use of oral voriconazole in severe ulcers reduces the rate of perforations. 240 fungal corneal ulcers with baseline visual acuity worse than 6/120 presenting to the Aravind Eye Hospitals and the UCSF Proctor Foundation will be randomized to receive topical voriconazole and oral voriconazole, or topical voriconazole and oral placebo. The primary outcome is the rate of perforation over the three month follow-up period.

Study Design

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


Corneal Ulcer


Voriconazole, Placebo


Proctor Foundation, UCSF
San Francisco
United States




University of California, San Francisco

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:12:26-0400

Clinical Trials [611 Associated Clinical Trials listed on BioPortfolio]

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.

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

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...

Cross-linking for Corneal Ulcers Treatment Trial

The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal...

Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole

To evaluate the drug-drug interaction between rifampicin and voriconazole according to CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole

Steroids for Corneal Ulcers Trial

The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.

PubMed Articles [1598 Associated PubMed Articles listed on BioPortfolio]

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.

Corneal ulcer as the presenting feature of type 2 diabetes mellitus.

A 60-year-old woman, with no significant medical or ophthalmic history, presented with a unilateral large corneal ulcer and hypopyon. Despite a severely injected conjunctiva and large corneal epitheli...

Topical pentoxifylline for pressure ulcer treatment: a randomised, double-blind, placebo-controlled clinical trial.

To evaluate the effectiveness of topical pentoxifylline (PTX) on pressure ulcer (PU) healing in critically ill patients.

Biomechanics and Structure of the Cornea: Implications and Association with Corneal Disorders.

Recent studies have shown that alterations in corneal biomechanical properties are associated with corneal pathologies, particularly corneal ectasia. Moreover, these alterations may have implications ...

Involvement of Toll-like receptor 2 on human corneal epithelium during an infection of Pythium insidiosum.

Pythium insidiosum, a pathogenic oomycete, is a common causative organism of infectious corneal ulcer. Studying the innate immune response at the ocular surface is important for better understanding o...

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.

Loss of epithelial tissue from the surface of the cornea due to progressive erosion and necrosis of the tissue; usually caused by bacterial, fungal, or viral infection.

The measurement of curvature and shape of the anterior surface of the cornea using techniques such as keratometry, keratoscopy, photokeratoscopy, profile photography, computer-assisted image processing and videokeratography. This measurement is often applied in the fitting of contact lenses and in diagnosing corneal diseases or corneal changes including keratoconus, which occur after keratotomy and keratoplasty.


Fibroblasts which occur in the CORNEAL STROMA.

More From BioPortfolio on "Mycotic Ulcer Treatment Trial II"

Quick Search


Relevant Topic

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Searches Linking to this Trial