A Phase 2 interventional study of Auriclosene Solution 0.3% and Auriclosene Vehicle in Bacterial Conjunctivitis, sponsored by NovaBay Pharmaceuticals, Inc.. Completed at 21 sites in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-05-28.
Sponsored by NovaBay Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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:
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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 217 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →NovaBay Pharmaceuticals, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Dosed QID for 4 Days
Drug: Auriclosene Solution 0.3%
Dosed QID for 4 days
Drug: Auriclosene Vehicle
Ophthalmic solution dispensed as drops onto the eye
Also known as: NVC-422
Ophthalmic Vehicle solution dispensed as drops onto the eye
Microbiological Success
Eradication of all pre-therapy isolates
Time frame: 5 days
Clinical Cure
Resolution of all signs and symptoms
Time frame: 5 days
Resolution of individual ocular signs and symptoms
Time frame: 5 days
The record gives a start of Jun 2013, a primary completion of Dec 2014 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NVC-422
NovaBay Pharmaceuticals, Inc.