Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis (BAYnovation™)
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|ClinicalTrials.gov Identifier: NCT01532336|
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : May 28, 2015
The purpose of this study is to evaluate the clinical and microbiological efficacy and safety of NVC-422 compared to vehicle for adenoviral conjunctivitis. Adults and children one year of age and older with diagnosis of adenoviral conjunctivitis in at least one eye based upon a positive adenovirus test result using the Aden-Detactor Plus kit (Rapid Pathogen Screening, Inc).
Subjects will be randomly assigned to receive either NVC-422 or Vehicle.
|Condition or disease||Intervention/treatment||Phase|
|Adenoviral Conjunctivitis||Drug: NVC-422 Solution, 0.3% Drug: NVC-422 Vehicle Solution||Phase 2|
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: NVC-422 Ophthalmic Solution 0.33% ("NVC-422") and NVC-422 Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 6 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3
- Visit 3: Day 6
- Visit 4: Day 11 End of Treatment (EOT)
- Visit 5: Day 18 Test-of-Cure (TOC)
- Visit 6: Day 42 Follow-up
Subjects were dosed OU for 10 days. Specimens were collected OU at each visit for quantitative PCR adenoviral load and molecular typing.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||August 2014|
Experimental: NVC-422 Solution, 0.3%
Dosed for 10 days
Drug: NVC-422 Solution, 0.3%
NVC-422 Ophthalmic Solution dropped onto the eye
Other Name: Auriclosene
Placebo Comparator: NVC-422 Vehicle Solution
Dosed for 10 days
Drug: NVC-422 Vehicle Solution
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
- Sustained Clinical Cure [ Time Frame: Day 18 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532336
Show 58 Study Locations
|Study Director:||David Stroman, Ph.D.||NovaBay Pharmaceuticals, Inc.|