Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis (BAYnovation™)

NovaBay Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Adenoviral Conjunctivitis

Treatments

Drug: NVC-422 Vehicle Solution

Drug: NVC-422 Solution, 0.3%

Study type

Interventional

Funder types

Industry

Identifiers

NCT01532336

BAYnovation (Other Identifier)

CL1104

Details and patient eligibility

About

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 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.

Enrollment

500 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

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