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Clinical Trial 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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01532336
Study type Interventional
Source NovaBay Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date May 2012
Completion date August 2014

See also
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Active, not recruiting NCT03856645 - OKG-0301 for the Treatment of Acute Adenoviral Conjunctivitis Phase 2
Completed NCT00266734 - Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears N/A
Completed NCT03749317 - Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Viral Conjunctivitis Phase 2