Trial Outcomes & Findings for Viral Conjunctivitis Treatment Study (NCT NCT03861728)
NCT ID: NCT03861728
Last Updated: 2021-12-29
Results Overview
This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Up to 8 days
Results posted on
2021-12-29
Participant Flow
Participant milestones
| Measure |
Viral Conjunctivitis Treatment
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
|
Viral Conjunctivitis Placebo
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Viral Conjunctivitis Treatment Study
Baseline characteristics by cohort
| Measure |
Viral Conjunctivitis Treatment
n=6 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
|
Viral Conjunctivitis Placebo
n=5 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
48 years
n=7 Participants
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Duration of Symptoms Prior to Presentation
|
3 days
n=5 Participants
|
1 days
n=7 Participants
|
3 days
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 daysPopulation: All participants who received at least one dose of treatment or placebo and returned for follow up.
This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.
Outcome measures
| Measure |
Viral Conjunctivitis Treatment
n=6 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
|
Viral Conjunctivitis Placebo
n=5 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
|
|---|---|---|
|
Number of Participants With Clinical Resolution of Viral Conjunctivitis
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: All participants who received at least one dose of treatment or placebo and returned for follow up.
This is the number of participants who on day 7 (+/-1 days) answered on clinical questionaire "none" or "mild" to each of the following list of 7 symptoms: "overall symptoms that affect your daily activities", "itching", "tearing", "pain", "feeling that your lids are stuck together in the morning", "sensitivity to light", "blurry vision"
Outcome measures
| Measure |
Viral Conjunctivitis Treatment
n=6 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
|
Viral Conjunctivitis Placebo
n=5 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
|
|---|---|---|
|
Number of Participants With Symptomatic Resolution of Viral Conjunctivitis
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 8 daysPopulation: All participants who received at least one dose of treatment or placebo and returned for follow up.
This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct \> 35)
Outcome measures
| Measure |
Viral Conjunctivitis Treatment
n=6 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
|
Viral Conjunctivitis Placebo
n=5 Participants
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
|
|---|---|---|
|
Number of Participants With Undetectable Adenoviral DNA
|
3 Participants
|
1 Participants
|
Adverse Events
Viral Conjunctivitis Treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Viral Conjunctivitis Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Viral Conjunctivitis Treatment
n=6 participants at risk
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid
0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
|
Viral Conjunctivitis Placebo
n=5 participants at risk
Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline
Placebo: Placebo to be used four times a day to the affected eye for 2 weeks
|
|---|---|---|
|
Eye disorders
HSV Keratitis
|
16.7%
1/6 • Number of events 1 • 3 weeks
|
0.00%
0/5 • 3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place