NCT04041856

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

July 24, 2019

Last Update Submit

July 30, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

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

    Decreased patient's symptoms

    3 months

  • Povidone-iodine 2% eye drop

    Decreased viral load based on PCR results

    3 months

Study Arms (2)

EKC patients

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

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

Also known as: Povidone-iodine 2%
EKC patients

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suspected for viral conjunctivitis

You may not qualify if:

  • Allergic to iodized materials
  • Age under 17

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Mohammad Soleimani, professor

CONTACT

Arash Mirzaei, Resident

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of ophthalmology

Study Record Dates

First Submitted

July 24, 2019

First Posted

August 1, 2019

Study Start

August 23, 2019

Primary Completion

October 22, 2019

Study Completion

November 22, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07