Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis (BAYnovation™)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01532336 |
|
Recruitment Status :
Completed
First Posted : February 14, 2012
Last Update Posted : May 28, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adenoviral Conjunctivitis | Drug: NVC-422 Solution, 0.3% Drug: NVC-422 Vehicle Solution | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | August 2014 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: NVC-422 Solution, 0.3%
Dosed for 10 days
|
Drug: NVC-422 Solution, 0.3%
NVC-422 Ophthalmic Solution dropped onto the eye
Other Name: Auriclosene |
|
Placebo Comparator: NVC-422 Vehicle Solution
Dosed for 10 days
|
Drug: NVC-422 Vehicle Solution
NVC-422 Vehicle Ophthalmic Solution dropped onto the eye |
- Sustained Clinical Cure [ Time Frame: Day 18 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532336
Show 58 study locations
| Study Director: | David Stroman, Ph.D. | NovaBay Pharmaceuticals, Inc. |
| Responsible Party: | NovaBay Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01532336 |
| Other Study ID Numbers: |
CL1104 BAYnovation ( Other Identifier: NovaBay ) |
| First Posted: | February 14, 2012 Key Record Dates |
| Last Update Posted: | May 28, 2015 |
| Last Verified: | July 2014 |
|
adenovirus conjunctivitis pinkeye |
|
Conjunctivitis, Inclusion Conjunctivitis Conjunctival Diseases Eye Diseases Conjunctivitis, Bacterial Eye Infections, Bacterial Bacterial Infections |
Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Eye Infections Infection Pharmaceutical Solutions |