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.
Full Title of Study: “A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: May 2014
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.
- Drug: NVC-422 Solution, 0.3%
- NVC-422 Ophthalmic Solution dropped onto the eye
- Drug: NVC-422 Vehicle Solution
- NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
Arms, Groups and Cohorts
- Experimental: NVC-422 Solution, 0.3%
- Dosed for 10 days
- Placebo Comparator: NVC-422 Vehicle Solution
- Dosed for 10 days
Clinical Trial Outcome Measures
- Sustained Clinical Cure
- Time Frame: Day 18
Participating in This Clinical Trial
- Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
- Bulbar conjunctival injection
- Other inclusion criteria per protocol
- Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye
- A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
- Other exclusion criteria per protocol
Gender Eligibility: All
Minimum Age: 1 Year
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- NovaBay Pharmaceuticals, Inc.
- Provider of Information About this Clinical Study
- Overall Official(s)
- David Stroman, Ph.D., Study Director, NovaBay Pharmaceuticals, Inc.
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