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

This study is currently recruiting participants.

Verified April 2013 by NovaBay Pharmaceuticals, Inc.

Sponsor:

Information provided by (Responsible Party):

NovaBay Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01532336

First received: February 9, 2012

Last updated: April 17, 2013

Last verified: April 2013

History of Changes

Purpose

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 adenoviral conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either NVC-422 or Vehicle. Six visits will be required for this study.

Condition	Intervention	Phase
Adenoviral Conjunctivitis	Drug: NVC-422 Ophthalmic Solution, 0.33% Drug: Vehicle Ophthalmic Solution	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

U.S. FDA Resources

Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:

Sustained Clinical Cure [ Time Frame: Day 18 ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	May 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NVC-422 Ophthalmic Solution	Drug: NVC-422 Ophthalmic Solution, 0.33%
Placebo Comparator: Vehicle Ophthalmic Solution	Drug: Vehicle Ophthalmic Solution

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532336

Contacts

Contact: Susan M Iovino, BSMT(ASCP)

510-899-8853

siovino@novabaypharma.com

Show 39 Study Locations

Sponsors and Collaborators

NovaBay Pharmaceuticals, Inc.

Investigators

Study Director:

David Stroman, Ph.D.

NovaBay Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01532336 History of Changes
Other Study ID Numbers:	CL1104, BAYnovation
Study First Received:	February 9, 2012
Last Updated:	April 17, 2013
Health Authority:	United States: Food and Drug Administration Brazil: National Health Surveillance Agency India: Drugs Controller General of India

Keywords provided by NovaBay Pharmaceuticals, Inc.:

adenovirus
conjunctivitis
pinkeye

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial

Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection

ClinicalTrials.gov processed this record on May 19, 2013

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