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

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ClinicalTrials.gov Identifier: NCT03230058
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Charitha, L.V. Prasad Eye Institute

Brief Summary:

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 POPULATION Patients with smear and or culture proven fungal keratitis presenting to our Instituts, were eligible for enrollment.

STUDY DESIGN Prospective double masked randomized clinical trial.


Condition or disease Intervention/treatment Phase
Infection, Fungal Drug: Group 1 Natamycin 5% Suspension + voriconazole 1% eye drops; Group 2 Natamycin 5% Suspension + Vehicle eye drops Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Treatment of 5% Natamycin and 1% Voriconazole in Fungal Keratitis: a Prospective Randomized Double Masked Clinical Trial
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds

Arm Intervention/treatment
Experimental: group 1

Once the patient is randomized to either of the 2 groups using computer-generated randomization blocks, the hospital pharmacist would provide the appropriate medications. The treating ophthalmologist, microbiologist and patients will be masked to the drug by using similar vials. The experimental group (Group 1) will receive 1% voriconazole eye drop (Aurolab, Madurai, India) + 5% Natamycin ophthalmic suspension eye drop hourly (USP 5% Natamet, M.J. Pharmaceuticals, Mumbai, India).

The subjects will be hospitalized for at least 4 days with medications given by the ward nurse.

Patients will be followed up every week after being discharged until complete resolution is noted.

Drug: Group 1 Natamycin 5% Suspension + voriconazole 1% eye drops; Group 2 Natamycin 5% Suspension + Vehicle eye drops
instillation of drops

Placebo Comparator: group 2

Once the patient is randomized to either of the 2 groups using computer-generated randomization blocks, the hospital pharmacist would provide the appropriate medications. The treating ophthalmologist, microbiologist and patients will be masked to the drug by using similar vials. The placebo group (Group 2) will receive Vehicle eye drops + 5% Natamycin ophthalmic suspension every hour (USP 5% Natamet, M.J. Pharmaceuticals, Mumbai, India).

The subjects will be hospitalized for at least 4 days with medications given by the ward nurse.

Patients will be followed up every week after being discharged until complete resolution is noted.

Drug: Group 1 Natamycin 5% Suspension + voriconazole 1% eye drops; Group 2 Natamycin 5% Suspension + Vehicle eye drops
instillation of drops




Primary Outcome Measures :
  1. Success or failure [ Time Frame: 8 weeks ]

    Primary End point:

    Complete success: Complete resolution of the infiltrate with formation of a scar on medical treatment alone Partial success: Complete resolution of the infiltrate on medical treatment and use of cyanoacrylate glue and bandage contact lens Failure: Worsening of the ulcer necessitating therapeutic penetrating keratoplasty or evisceration



Secondary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: 8 weeks ]
    improvement in best corrected visual acuity



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects > 18 yrs of age Willing to give appropriate informed consent Presence of corneal ulcer measuring > 2mm in vertical and horizontal dimensions at presentation (epithelial defect and signs of stromal inflammation) Microbiologic evidence of fungus on smear and or culture media Willing to return for all the follow up visits

Exclusion Criteria:

  • Patients not willing to give consent Patients unable to cooperate for the procedure Patient with impending, or actual perforation or bilateral corneal ulcer or scleral involvement History of previous ocular surgery Evidence of bacterial, parasitic or viral infection or co-infection Previous corneal scar Known allergy to the study medication (drug or preservative) Pregnant or nursing females Immunocompromised patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230058


Contacts
Contact: Antonio Di Zazzo, MD antoniodizazzo@gmail.com
Contact: merle ferndnades, MS merle@lvpei.org

Locations
India
GMRV Campus LV Prasad Eye Insitute Recruiting
Visakhapatnam, Andhra Pradesh, India
Contact: Merle Fernandes, MS       merle@lvpei.org   
Contact: Antonio Di Zazzo, MD       antoniodizazzo@gmail.com   
Sponsors and Collaborators
L.V. Prasad Eye Institute
Investigators
Principal Investigator: merle fernandes, MS LVPEI

Publications of Results:
Other Publications:
Responsible Party: Charitha, MS, L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier: NCT03230058     History of Changes
Other Study ID Numbers: GMRV_NATA01
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Corneal Diseases
Keratitis
Mycoses
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Voriconazole
Natamycin
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP3A Inhibitors
Anti-Infective Agents, Local
Anti-Bacterial Agents