Last updated: 11/07/2018 08:34:04

A Meta Analysis to compare the efficacy of Acyclovir 3% ophthalmic ointment to Idoxuridine in curing herpes keratitis after 7-days of treatment

GSK study ID
115067
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Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Meta Analysis to compare the efficacy of Acyclovir 3% ophthalmic ointment to Idoxuridine in curing herpes keratitis after 7-days of treatment
Trial description: Acyclovir 3% ophthalmic ointment has been evaluated for the treatment of herpes simplex keratitis (HSK) in many clinical trials and has demonstrated healing rates superior to idoxuridine (Dendrid®) and comparable to trifluridine (Viroptic®) (Wilhelmus, 2009). Both idoxuridine and trifluridine are currently approved in the United States for the treatment of herpes simplex keratitis.
The objective of this meta analysis is to to compare the efficacy of acyclovir 3% ophthalmic ointment to idoxuridine in curing herpes keratitis after 7-days of treatment. The null hypothesis is that the efficacy of acyclovir ophthalmic ointment is similar to idoxuridine and the alternative is that it is superior to idoxuridine
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

healing

Timeframe: 7 days

Secondary outcomes:
Not applicable
Interventions:
  • Drug: acyclovir
  • Drug: idoxuridine
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Diane E. Balderson,Gengqian Cai, Michael A. Fries, David M. Kleinman, Megan M. McLaughlin,Trupti M. Trivedi, John I. Wurzelmann, Sheila B. Young. A systematic review and meta-analysis to compare the efficacy of acyclovir 3% ophthalmic ointment to idoxuridine in curing herpetic keratitis by Day 7 of treatment. BMC Ophthalmol. 2015;15:42.
    Medical condition
    Herpes Simplex, Ocular
    Product
    aciclovir
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to April 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    1 - 100 Year
    Accepts healthy volunteers
    none
    • N/A
    • N/A
    Inclusion and exclusion criteria
    Inclusion criteria:
    • N/A
    Exclusion criteria:
    • N/A

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-09-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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