Trial Outcomes & Findings for Reducing Adenoviral Patient Infected Days (NCT NCT02472223)

NCT ID: NCT02472223

Last Updated: 2021-01-06

Results Overview

To compare efficacy of Betadine 5% to artificial tears to change from peak viral load in Adenoviral conjunctivitis

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

21 days

Results posted on

2021-01-06

Participant Flow

Participants, who are ≥ 18 years of age and report symptom in the first affected eye onset ≤ 4 days, will be informed of the study by Clinical Center personnel and asked if they would be interested in learning more.

Participant milestones

Participant milestones
Measure	Betadine 5% One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.	Artificial Tears One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
Overall Study STARTED	16	12
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We only analyzed those participant who were qPCR positive.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 21 days

Population: Subgroup of 16 patients randomized to Betadine and 12 patients randomized to artificial tears who tested positive for adenoviral conjunctivitis by qPCR at baseline. Viral load was assessed at baseline, post treatment follow-up days at 1-2, 4-5, 7, 14 and 21.

To compare efficacy of Betadine 5% to artificial tears to change from peak viral load in Adenoviral conjunctivitis

Outcome measures

Outcome measures
Measure	Betadine 5% n=16 Participants One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.	Artificial Tears n=12 Participants One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
Percent Change From Peak Viral Load	1.9 Percent of peak Viral Load Interval 0.0 to 7.6	13.2 Percent of peak Viral Load Interval 1.0 to 32.3

SECONDARY outcome

Timeframe: 21 days

Population: Patient reported bothersomeness of ocular symptoms was assessed at baseline, post treatment follow-up days at 1-2, 4-5, 7, 14 and 21.

Participants reported bothersomeness of ocular symptoms on a 10 point scale 0=not at all. 10=very bothersome

Outcome measures

Outcome measures
Measure	Betadine 5% n=16 Participants One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.	Artificial Tears n=12 Participants One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
Participant Reported Bothersomeness of Ocular Symptoms	4.5 Unit on a scale Interval 0.0 to 10.0	8.0 Unit on a scale Interval 0.0 to 10.0

Adverse Events

Betadine 5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Artificial Tears

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mae Gordon

Washington University School of Medicine

Phone: 3143623716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Betadine 5% n=16 Participants One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.	Artificial Tears n=12 Participants One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	0 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	0 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	11 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	26 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Age, Categorical >=65 years	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	2 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Sex: Female, Male Female	8 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	7 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	15 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Sex: Female, Male Male	8 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	5 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	13 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	2 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	5 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	9 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	22 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	5 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) Asian	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	0 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	4 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	11 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) White	3 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	5 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	8 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	0 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	1 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.
Region of Enrollment United States	16 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.	12 Participants n=7 Participants • We only analyzed those participant who were qPCR positive.	28 Participants n=5 Participants • We only analyzed those participant who were qPCR positive.