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

NCT01532336 | Completed Phase 2

• 2 other identifiers: CL1104BAYnovation
• Study Type: interventional
• Target: 500
• Locations: 4 countries
• Sites: 58

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.

Conditions

Adenoviral Conjunctivitis

Keywords

adenovirus; conjunctivitis; pinkeye

Outcome Measures

Primary Outcomes (1)

• Sustained Clinical Cure

  Day 18

Study Arms (2)

NVC-422 Solution, 0.3%

EXPERIMENTAL

Dosed for 10 days

Drug: NVC-422 Solution, 0.3%

NVC-422 Vehicle Solution

PLACEBO COMPARATOR

Dosed for 10 days

Drug: NVC-422 Vehicle Solution

Interventions

NVC-422 Solution, 0.3% DRUG

NVC-422 Ophthalmic Solution dropped onto the eye

Also known as: Auriclosene

NVC-422 Solution, 0.3%

NVC-422 Vehicle Solution DRUG

NVC-422 Vehicle Ophthalmic Solution dropped onto the eye

NVC-422 Vehicle Solution

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signs and symptoms of viral conjunctivitis in at least one eye for 3 days or less
• Bulbar conjunctival injection

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaBay Pharmaceuticals, Inc.: lead

Study Sites (58)

Unknown Facility

Glendale, California, 91205, United States

Location

Unknown Facility

Los Angeles, California, 90048, United States

Location

Unknown Facility

Petaluma, California, 94954, United States

Location

Unknown Facility

San Diego, California, 92115, United States

Location

Unknown Facility

Fort Myers, Florida, 33901, United States

Location

Unknown Facility

Jacksonville Beach, Florida, 32250, United States

Location

Unknown Facility

Tampa, Florida, 33603, United States

Location

Unknown Facility

Albany, Georgia, 31701, United States

Location

Unknown Facility

Kailua, Hawaii, 96734, United States

Location

Unknown Facility

Glenview, Illinois, 60026, United States

Location

Unknown Facility

Peoria, Illinois, 61615, United States

Location

Unknown Facility

Shawnee Mission, Kansas, 66204, United States

Location

Unknown Facility

Hazard, Kentucky, 41701, United States

Location

Unknown Facility

Winchester, Massachusetts, 01890, United States

Location

Unknown Facility

Kansas City, Missouri, 64154, United States

Location

Unknown Facility

St Louis, Missouri, 63131, United States

Location

Unknown Facility

Hicksville, New York, 11801, United States

Location

Unknown Facility

Rockville Centre, New York, 11570, United States

Location

Unknown Facility

Asheville, North Carolina, 28803, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27101, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15206, United States

Location

Unknown Facility

Charleston, South Carolina, 29414, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29306, United States

Location

Unknown Facility

Recife, Pernambuco, 50070-040, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Unknown Facility

Joinville, Santa Catarina, 89201-010, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01221-020, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04023-062, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04502-001, Brazil

Location

Unknown Facility

Sorocaba, São Paulo, 18031-060, Brazil

Location

Unknown Facility

Hyderabad, Andhra Pradesh, 500 034, India

Location

Unknown Facility

Hyderabad, Andhra Pradesh, 500 096, India

Location

Unknown Facility

Ahmedabad, Gujarat, 380 016, India

Location

Unknown Facility

Surat, Gujarat, 395 001, India

Location

Unknown Facility

Bangalore, Karnataka, 560 010, India

Location

Unknown Facility

Bangalore, Karnataka, 560 054, India

Location

Unknown Facility

Thiruvanathapuram, Kerala, 695 011, India

Location

Unknown Facility

Mumbai, Maharashtra, 400 004, India

Location

Unknown Facility

Mumbai, Maharashtra, 400 020, India

Location

Unknown Facility

Mumbai, Maharashtra, 400 080, India

Location

Unknown Facility

Mumbai, Maharashtra, 400 602, India

Location

Unknown Facility

Daryāganj, New Dehli, 110 002, India

Location

Unknown Facility

New Dehli, New Dehli, 110 608, India

Location

Unknown Facility

Bikaner, Rajasthan, 334 001, India

Location

Unknown Facility

Jaipur, Rajasthan, 302 004, India

Location

Unknown Facility

Jaipur, Rajasthan, 302 015, India

Location

Unknown Facility

Chennai, Tamil Nadu, 600 010, India

Location

Unknown Facility

Salem, Tamil Nadu, 636 004, India

Location

Unknown Facility

Visakhapatnam, Vishakhapatnam, 530 013, India

Location

Unknown Facility

Kolkata, West Bengal, 700 073, India

Location

Unknown Facility

Colombo, 01000, Sri Lanka

Location

Unknown Facility

Colombo, 11010, Sri Lanka

Location

Unknown Facility

Colombo, Sri Lanka

Location

Unknown Facility

Kalubowila, 10350, Sri Lanka

Location

Unknown Facility

Negombo, 11500, Sri Lanka

Location

Unknown Facility

Nugegoda, 10250, Sri Lanka

Location

MeSH Terms

Conditions

Adenoviridae Infections; Conjunctivitis

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Conjunctival Diseases; Eye Diseases

Study Officials

• David Stroman, Ph.D.

  NovaBay Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 14, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 28, 2015

Record last verified: 2014-07

Locations

US (24); SR (6); BR (8); IN (20)