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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adenoviral Conjunctivitis

Intervention / Treatment
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* Drug: NVC-422 Solution, 0.3%
* Drug: NVC-422 Vehicle Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVC-422 Solution, 0.3%<br>Dosed for 10 days | Drug: NVC-422 Solution, 0.3%<br>* NVC-422 Ophthalmic Solution dropped onto the eye<br>* Other names: Auriclosene;|
| Placebo Comparator: NVC-422 Vehicle Solution<br>Dosed for 10 days | Drug: NVC-422 Vehicle Solution<br>* NVC-422 Vehicle Ophthalmic Solution dropped onto the eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Clinical Cure |  | Day 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenovirus, conjunctivitis, pinkeye