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Also known as Moxifloxacin ophthalmic solution, 0.5%
Moxifloxacin, 0.5% · 1 trial · 1 indication
Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.
Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin | EXPERIMENTAL | Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 |
| Ofloxacin | ACTIVE_COMPARATOR | Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 |
| Name | Type | Description |
|---|---|---|
| Moxifloxacin ophthalmic solution, 0.5% | DRUG | - |
| Ofloxacin ophthalmic solution, 0.3% | DRUG | - |
Inclusion Criteria: * Chinese. * Diagnosis of bacterial conjunctivitis based on clinical observation. * Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informe...
Moxifloxacin, 0.5% is an ophthalmic solution being developed for the treatment of bacterial conjunctivitis. It is applied topically to the eye. The Phase 3 program studied it in Chinese patients with bacterial conjunctivitis, including children as young as 1 year old.
Alcon Inc. (ticker: ALC) is the developer of moxifloxacin ophthalmic solution, 0.5%. The company sponsored the clinical evaluation of the product for bacterial conjunctivitis. Alcon is an eye care focused pharmaceutical and device company.
Yes. Moxifloxacin, 0.5% and moxifloxacin ophthalmic solution, 0.5% refer to the same product. The longer name describes the dosage form and concentration, a 0.5% topical eye drop formulation. Searches using either name point to the same Alcon asset under development for bacterial conjunctivitis.
Moxifloxacin, 0.5% has been studied in Phase 3 clinical development for bacterial conjunctivitis. The single Phase 3 trial in the program is completed, and no trials are currently active. It is an investigational ophthalmic product rather than a newly approved therapy in this development program.
Moxifloxacin, 0.5% was evaluated in one completed Phase 3 trial, NCT01573910. The study compared moxifloxacin ophthalmic solution 0.5% with ofloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in Chinese patients. It enrolled 985 participants, was randomized, and used an active control design.
Moxifloxacin, 0.5% is a small molecule antibacterial agent delivered as a topical ophthalmic solution. It is designed to act against the bacteria that cause conjunctivitis. The Phase 3 study compared it directly with ofloxacin ophthalmic solution 0.3%, an active antibacterial comparator, in patients with bacterial conjunctivitis.