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Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis

Primary Purpose

Adenoviral Keratoconjunctivitis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Povidone Ophthalmic
Sponsored by
Farabi Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoviral Keratoconjunctivitis

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suspected for viral conjunctivitis

Exclusion Criteria:

  • Allergic to iodized materials
  • Age under 17

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    EKC patients

    Control group

    Arm Description

    Povidone-iodine 2% eye drop will be prescribed four times a day All patients will learn how to improve the hygiene level in order to reduce transmission

    All patients will undergo observational treatments including artificial tear drop and improving hygiene level

    Outcomes

    Primary Outcome Measures

    Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
    Decreased patient's symptoms
    Povidone-iodine 2% eye drop
    Decreased viral load based on PCR results

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2019
    Last Updated
    July 30, 2019
    Sponsor
    Farabi Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04041856
    Brief Title
    Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
    Official Title
    Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 23, 2019 (Anticipated)
    Primary Completion Date
    October 22, 2019 (Anticipated)
    Study Completion Date
    November 22, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Farabi Eye Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
    Detailed Description
    Diagnosed EKC patients will be devided into two groups,first group will undergo povidone-iodine 2% eye drop four times a day and the control group will be treated only by artificial tear drops,they will be examined 3 months later and evaluations and data collections for the final comparison will be done.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenoviral Keratoconjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EKC patients
    Arm Type
    Active Comparator
    Arm Description
    Povidone-iodine 2% eye drop will be prescribed four times a day All patients will learn how to improve the hygiene level in order to reduce transmission
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    All patients will undergo observational treatments including artificial tear drop and improving hygiene level
    Intervention Type
    Drug
    Intervention Name(s)
    Povidone Ophthalmic
    Other Intervention Name(s)
    Povidone-iodine 2%
    Intervention Description
    Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
    Primary Outcome Measure Information:
    Title
    Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
    Description
    Decreased patient's symptoms
    Time Frame
    3 months
    Title
    Povidone-iodine 2% eye drop
    Description
    Decreased viral load based on PCR results
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suspected for viral conjunctivitis Exclusion Criteria: Allergic to iodized materials Age under 17
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammad Soleimani, professor
    Phone
    00989121096496
    Email
    Soleimani_md@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arash Mirzaei, Resident
    Phone
    00989126424299
    Email
    drarashmirzaei@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis

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