- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041856
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
July 30, 2019 updated by: mohammad soleimani, Farabi Eye Hospital
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammad Soleimani, professor
- Phone Number: 00989121096496
- Email: Soleimani_md@yahoo.com
Study Contact Backup
- Name: Arash Mirzaei, Resident
- Phone Number: 00989126424299
- Email: drarashmirzaei@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients suspected for viral conjunctivitis
Exclusion Criteria:
- Allergic to iodized materials
- Age under 17
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Other Names:
|
No Intervention: Control group
All patients will undergo observational treatments including artificial tear drop and improving hygiene level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Time Frame: 3 months
|
Decreased patient's symptoms
|
3 months
|
Povidone-iodine 2% eye drop
Time Frame: 3 months
|
Decreased viral load based on PCR results
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 23, 2019
Primary Completion (Anticipated)
October 22, 2019
Study Completion (Anticipated)
November 22, 2019
Study Registration Dates
First Submitted
July 24, 2019
First Submitted That Met QC Criteria
July 30, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
August 1, 2019
Last Update Submitted That Met QC Criteria
July 30, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- farabieyehospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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