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Modified Treatment for Epidemic Keratoconjunctivitis (EKC) (EKC)

Primary Purpose

Symptoms and Signs

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Povidone-Iodine
Normal Saline Flush
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptoms and Signs

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Including adult patients with 18 to 60 years old
  • Patients with BCDVA of ≥ 20/80 in the study eye
  • If the patent have bilateral EKC only one eye included in the study
  • Patients attending all the required follow up visits as advised.

Exclusion Criteria:

  • Children
  • Patients with ocular infection rather than EKC
  • Patients with corneal ulceration or bacterial keratitis
  • Immunocompromised patients
  • Glaucoma
  • Patients not attending the required follow up visits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Modified method

    Ordinary method

    Arm Description

    Povidone Iodine

    normal saline

    Outcomes

    Primary Outcome Measures

    Ocular symptoms of epidemic keratoconjunctivitis
    Ocular symptoms of epidemic keratoconjunctivitis include the following 1-Lid swelling. 2-Red eyes. 3- Watery discharge. 4- Photophobia. 5- Eye discomfort . Each symptom evaluated with grade severity:- Normal= no abnormality (0 score), mild= subtle abnormality (1-2 score), moderate= obvious abnormality (3-4 score) and severe = marked abnormality (5 score). the minimum value was 0 score and means better outcome and maximum score is 5 and means worse outcome.
    Ocular signs of epidemic keratoconjunctivitis
    Ocular signs of epidemic keratoconjunctivitis include the following 1- Lid edema. 2- Follicular conjunctivitis. 3-Pseudomembrane formation. 4- Punctate epithelial keratitis. Each sign evaluated with grade severity:- Normal= no abnormality (0 score), mild= subtle abnormality (1-2 score), moderate= obvious abnormality (3-4 score) and severe = marked abnormality (5 score). the minimum value was 0 score and means better outcome and maximum score is 5 and means worse outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 13, 2019
    Last Updated
    November 18, 2019
    Sponsor
    Minia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04169919
    Brief Title
    Modified Treatment for Epidemic Keratoconjunctivitis (EKC)
    Acronym
    EKC
    Official Title
    Povidone Iodine 5% Eye Wash in Treatment of Epidemic Keratoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    October 2018 (Actual)
    Study Completion Date
    October 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Minia University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Background: Epidemic Keratoconjunctivitis (EKC) is a form of adenoviral conjunctivitis. It is highly infectious disease mainly affect the outer eye surface and has a frequency to happen in epidemics especially in closed communities such as hospitals, schools and factories. purpose: The purpose of this study to compare between the modified and the ordinary method of treatment for EKC. Patients and methods: Three hundred fifty patients of EKC were enrolled in the study. The diagnosis was made by clinical picture and laboratory investigations. Group 1 had two hundred patients 120 males, 80 females (age from 18 to 60 years) were treated by the modified method and group 2 had one hundred fifty patients 100 males,50 females (age from 18 to 58 years) were treated with the ordinary method. The study was hold between November 2014 to October 2018 in Security forces Hospital, Riyadh, Saudi Arabia. Patients were followed up for 3 months up to 2 years. The main outcome were improvement in clinical picture and recovery.
    Detailed Description
    Patients and Methods Three hundred fifty patients suffered from EKC were enrolled in the study. Their diagnosis was made by clinical picture and laboratory investigations. Group 1 had two hundred patients 120 males, 80 females (age from 18 to 60 years) were treated by the modified method and group 2 had one hundred fifty patients 100 males,50 females (age from 18 to 58 years) were treated with the ordinary method. The study was done between November 2014 to October 2018 in Security forces Hospital, Riyadh, Saudi Arabia. Patients were followed up for 3 months up to 2 years. The main outcomes were improvement in patients clinical picture and recovery. All patients signed a consent for inclusion in the study and the study was approved by the ethical committee and it was in agreement with declaration of Helsinki tents. All cases were diagnosed by clinical symptoms and signs as shown in table (2& 3) and conjunctival smear for some suspected patients which revealed lymphocytes predominance. Slit lamp examination and visual acuity measurement were done and grading of ocular symptoms and signs were estimated according to severerity into normal, mild, moderate or severe. The patients were divided into group 1 in which patients were treated by the modified method (Povidone Iodine 5% eye wash irrigation) and group 2 in which patients were treated by the ordinary method. Modified method The eye was topically anesthetized, then eye wash with Povidone Iodine 5% (povidone-iodine, Alcon) eye irrigation every day until the patients recovered. Manual removal of pseudo membranes with non toothed forceps and cotton tipped applicator on slit lamp. Antibiotic eye drops (moxifloxacin 0.5%) QID. Lubricant eye drops (tears natural free minims eye drops) QID. Cold compresses. Topical corticosteroid eye drops (fluorometholone 0.1%) QID in cases of subepithelial infiltrates or pseudomemrane formation. Usual method The same way of management except the eye wash with Povidone Iodine 5% . Steroids was used for symptomatic relief but it do not lower the disease pathway. It suppress the corneal inflammation, improve overall comfort but they also prolong clearance of the virus and the lesions may recur if steroid is prematurely discontinued.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptoms and Signs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1 modified method Group 2 ordinary method
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    350 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified method
    Arm Type
    Active Comparator
    Arm Description
    Povidone Iodine
    Arm Title
    Ordinary method
    Arm Type
    Active Comparator
    Arm Description
    normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    Povidone-Iodine
    Other Intervention Name(s)
    Group1
    Intervention Description
    Povidone-Iodine 5% eye wash
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline Flush
    Other Intervention Name(s)
    Group 2
    Intervention Description
    Normal Saline eye wash
    Primary Outcome Measure Information:
    Title
    Ocular symptoms of epidemic keratoconjunctivitis
    Description
    Ocular symptoms of epidemic keratoconjunctivitis include the following 1-Lid swelling. 2-Red eyes. 3- Watery discharge. 4- Photophobia. 5- Eye discomfort . Each symptom evaluated with grade severity:- Normal= no abnormality (0 score), mild= subtle abnormality (1-2 score), moderate= obvious abnormality (3-4 score) and severe = marked abnormality (5 score). the minimum value was 0 score and means better outcome and maximum score is 5 and means worse outcome.
    Time Frame
    2 weeks
    Title
    Ocular signs of epidemic keratoconjunctivitis
    Description
    Ocular signs of epidemic keratoconjunctivitis include the following 1- Lid edema. 2- Follicular conjunctivitis. 3-Pseudomembrane formation. 4- Punctate epithelial keratitis. Each sign evaluated with grade severity:- Normal= no abnormality (0 score), mild= subtle abnormality (1-2 score), moderate= obvious abnormality (3-4 score) and severe = marked abnormality (5 score). the minimum value was 0 score and means better outcome and maximum score is 5 and means worse outcome.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Including adult patients with 18 to 60 years old Patients with BCDVA of ≥ 20/80 in the study eye If the patent have bilateral EKC only one eye included in the study Patients attending all the required follow up visits as advised. Exclusion Criteria: Children Patients with ocular infection rather than EKC Patients with corneal ulceration or bacterial keratitis Immunocompromised patients Glaucoma Patients not attending the required follow up visits.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shaaban A Elwan, MD
    Organizational Affiliation
    Minia University and SFH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    methods
    IPD Sharing Time Frame
    2 years
    IPD Sharing Access Criteria
    Methods and results
    Citations:
    PubMed Identifier
    21916618
    Citation
    Trinavarat A, Atchaneeyasakul LO. Treatment of epidemic keratoconjunctivitis with 2% povidone-iodine: a pilot study. J Ocul Pharmacol Ther. 2012 Feb;28(1):53-8. doi: 10.1089/jop.2011.0082. Epub 2011 Sep 14.
    Results Reference
    background

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    Modified Treatment for Epidemic Keratoconjunctivitis (EKC)

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