Efficacy and Safety of NVC-422 in the Treatment of Adenoviral Conjunctivitis
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 1 - Any |
| Updated: | 5/3/2014 |
| Start Date: | May 2012 |
| End Date: | December 2013 |
| Contact: | Susan M Iovino, BSMT(ASCP) |
| Email: | siovino@novabaypharma.com |
| Phone: | 510-899-8853 |
A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
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.
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.
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
We found this trial at
25
sites
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