Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00105469 | Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004) | PHASE3 | COMPLETED | 743 | — | — | Jul 1, 2004 | Oct 1, 2005 | Dec 16, 2013 | 26 | United States |
| NCT00105534 | Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003) | PHASE3 | COMPLETED | 685 | — | — | Jul 1, 2004 | Jan 1, 2006 | Nov 21, 2013 | 32 | United States |
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.
| Arm | Type | Description |
|---|---|---|
| AzaSite | EXPERIMENTAL | 1.0% azithromycin in DuraSite |
| Tobramycin | ACTIVE_COMPARATOR | 0.3% tobramycin |
| Vehicle | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AzaSite | DRUG | AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5. |
| Tobramycin | DRUG | Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days. |
| Vehicle | OTHER | Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days. |
Inclusion Criteria: * Male or female subject, of any race, who is at least 1 year of age. * Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in ...