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ML Risk
AzaSite · 2 trials · 1 indication
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 ...
AzaSite is an investigational small molecule being developed for the treatment of bacterial conjunctivitis, a common eye infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being studied for its efficacy and safety in patients with this condition.
AzaSite is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for bacterial conjunctivitis.
AzaSite is in Phase 3 clinical development for bacterial conjunctivitis. It is an investigational drug, meaning it has not yet received regulatory approval. Two Phase 3 trials have been completed, but the drug remains under investigation and is not yet available to patients outside of clinical studies.
AzaSite has been studied in two completed Phase 3 clinical trials. NCT00105469 compared AzaSite to tobramycin in 743 patients with bacterial conjunctivitis. NCT00105534 compared AzaSite to a vehicle control in 685 patients. Both trials were conducted in the United States and enrolled patients as young as 12 months.
AzaSite is a brand name for an ophthalmic formulation of azithromycin, a macrolide antibiotic. While the active ingredient is azithromycin, AzaSite refers specifically to the eye drop formulation being developed by Merck for bacterial conjunctivitis. The drug is not yet approved and remains in clinical development.