Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis

Phase 2

Completed

• Conditions: Adenoviral Conjunctivitis
• Interventions: Drug: NVC-422 Solution, 0.3%; Drug: NVC-422 Vehicle Solution

• Registration Number: NCT01532336
• Lead Sponsor: NovaBay Pharmaceuticals, Inc.

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 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 Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Study Start: 2012-05
• Primary Completion: 2014-05
• Status Verified: 2014-07
• Study Completion: 2014-08
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
• Bulbar conjunctival injection
• Other inclusion criteria per protocol

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NVC-422 Solution, 0.3%	NVC-422 Solution, 0.3%	Dosed for 10 days
NVC-422 Vehicle Solution	NVC-422 Vehicle Solution	Dosed for 10 days

Primary Outcome Measures

Name	Time	Method
Sustained Clinical Cure	Day 18