Clinical Trial: Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: NovaBay Pharmaceuticals, Inc.
Current Primary Outcome: Sustained Clinical Cure [ Time Frame: Day 18 ]
Original Primary Outcome: Sustained Clinical Cure at Follow-up [ Time Frame: Day 18 ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NovaBay Pharmaceuticals, Inc.
Dates:
Date Received: February 9, 2012
Date Started: May 2012
Date Completion:
Last Updated: May 26, 2015
Last Verified: July 2014
