Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
NCT ID: NCT01532336
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
500 participants
INTERVENTIONAL
2012-05-31
2014-08-31
Brief Summary
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Subjects will be randomly assigned to receive either NVC-422 or Vehicle.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NVC-422 Solution, 0.3%
Dosed for 10 days
NVC-422 Solution, 0.3%
NVC-422 Ophthalmic Solution dropped onto the eye
NVC-422 Vehicle Solution
Dosed for 10 days
NVC-422 Vehicle Solution
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
Interventions
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NVC-422 Solution, 0.3%
NVC-422 Ophthalmic Solution dropped onto the eye
NVC-422 Vehicle Solution
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bulbar conjunctival injection
Exclusion Criteria
* A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation
1 Year
ALL
No
Sponsors
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NovaBay Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Stroman, Ph.D.
Role: STUDY_DIRECTOR
NovaBay Pharmaceuticals, Inc.
Locations
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Glendale, California, United States
Los Angeles, California, United States
Petaluma, California, United States
San Diego, California, United States
Fort Myers, Florida, United States
Jacksonville Beach, Florida, United States
Tampa, Florida, United States
Albany, Georgia, United States
Kailua, Hawaii, United States
Glenview, Illinois, United States
Peoria, Illinois, United States
Shawnee Mission, Kansas, United States
Hazard, Kentucky, United States
Winchester, Massachusetts, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Hicksville, New York, United States
Rockville Centre, New York, United States
Asheville, North Carolina, United States
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Recife, Pernambuco, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Joinville, Santa Catarina, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Ahmedabad, Gujarat, India
Surat, Gujarat, India
Bangalore, Karnataka, India
Bangalore, Karnataka, India
Thiruvanathapuram, Kerala, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Daryāganj, New Dehli, India
New Dehli, New Dehli, India
Bikaner, Rajasthan, India
Jaipur, Rajasthan, India
Jaipur, Rajasthan, India
Chennai, Tamil Nadu, India
Salem, Tamil Nadu, India
Visakhapatnam, Vishakhapatnam, India
Kolkata, West Bengal, India
Colombo, , Sri Lanka
Colombo, , Sri Lanka
Colombo, , Sri Lanka
Kalubowila, , Sri Lanka
Negombo, , Sri Lanka
Nugegoda, , Sri Lanka
Countries
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Other Identifiers
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BAYnovation
Identifier Type: OTHER
Identifier Source: secondary_id
CL1104
Identifier Type: -
Identifier Source: org_study_id
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