Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 1 - Any |
| Updated: | 7/11/2015 |
| Start Date: | June 2013 |
| End Date: | October 2014 |
| Contact: | David Stroman |
| Email: | dstroman@novabay.com |
A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis
The purpose of this study is to evaluate the microbiological and clinical efficacy of
Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one
year of age and older with bacterial conjunctivitis in at least one eye may be eligible.
Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or
Vehicle Ophthalmic Solution. Three visits will be required for this study.
Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one
year of age and older with bacterial conjunctivitis in at least one eye may be eligible.
Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or
Vehicle Ophthalmic Solution. Three visits will be required for this study.
Inclusion Criteria:
- 1 year of age and older
- Bulbar conjunctival injection
- Conjunctival discharge/exudate
- Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less
- Other inclusion criteria per protocol
Exclusion Criteria:
- Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical
diagnosis
- Any drug treatment in either eye for the current episode of bacterial conjunctivitis
prior to study enrollment
- Other exclusion criteria per protocol
We found this trial at
21
sites
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