Bacterial Conjunctivitis Clinical Trial
Official title:
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.
This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group
study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and
Auriclosene Vehicle ("Vehicle").
Subjects that meet all inclusion/exclusion criteria will be enrolled into the study,
randomized and evaluated at 3 visits:
- Visit 1: Screening, Day 1
- Visit 2: Day 3 (±1)
- Visit 3: Day 5 (+1) Test of Cure/Exit
IP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected
from each eye at each visit.
Visual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid
erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival
discharge/exudate.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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