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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01532336

Acronym

BAYnovation™

Enrollment

500

Registered

2012-02-14

Start date

2012-05-31

Completion date

2014-08-31

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoviral Conjunctivitis

Keywords

adenovirus, conjunctivitis, pinkeye

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.

Interventions

DRUGNVC-422 Solution, 0.3%

NVC-422 Ophthalmic Solution dropped onto the eye

DRUGNVC-422 Vehicle Solution

NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Sustained Clinical Cure	Day 18

Countries

Brazil, India, Sri Lanka, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026