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

Adenoviral Conjunctivitis Clinical Trial

— BAYnovation™  

Official title:

A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532336
• Other study ID #: CL1104
• Secondary ID: BAYnovation
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2012
• Last updated: May 26, 2015
• Start date: May 2012
• Est. completion date: August 2014

Study information

• Verified date: July 2014
• Source: NovaBay Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Health Surveillance AgencyIndia: Drugs Controller General of IndiaSri Lanka: Medical Technology & Supplies Sub-Committee on Clinical Trials
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

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

Related Conditions & MeSH terms

• Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• NVC-422 Solution, 0.3%
NVC-422 Ophthalmic Solution dropped onto the eye
• NVC-422 Vehicle Solution
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NovaBay Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  India,  Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Clinical Cure		Day 18	No