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

Sponsor
Farabi Eye Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04041856
Collaborator
(none)
200
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis

Condition or Disease Intervention/Treatment Phase
  • Drug: Povidone Ophthalmic
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
Anticipated Study Start Date :
Aug 23, 2019
Anticipated Primary Completion Date :
Oct 22, 2019
Anticipated Study Completion Date :
Nov 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: EKC patients

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

Drug: Povidone Ophthalmic
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Other Names:
  • Povidone-iodine 2%

    		•
    No Intervention: Control group

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

    Outcome Measures

    Primary Outcome Measures

    1. Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis [3 months]

      Decreased patient's symptoms

    2. Povidone-iodine 2% eye drop [3 months]

      Decreased viral load based on PCR results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients suspected for viral conjunctivitis
    Exclusion Criteria:

    • Allergic to iodized materials

    • Age under 17

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Farabi Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohammad soleimani, Associate professor of ophthalmology, Farabi Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT04041856
    Other Study ID Numbers:
    • farabieyehospital
    First Posted:
    Aug 1, 2019
    Last Update Posted:
    Aug 1, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keratoconjunctivitis
    Povidone-Iodine
    Povidone

    Study Results

    No Results Posted as of Aug 1, 2019