Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ofloxacin, 0.3% · 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...
Ofloxacin 0.3% is an ophthalmic solution used for the treatment of bacterial conjunctivitis, an infection of the outer membrane of the eye. It is a small molecule antibiotic administered as eye drops. The drug is being developed by Alcon Inc. for this infectious disease indication.
Alcon Inc. (NYSE: ALC) is the developer of Ofloxacin 0.3%. The company is conducting clinical development of this ophthalmic solution for the treatment of bacterial conjunctivitis. Alcon is a global medical device and pharmaceutical company specializing in eye care products.
Ofloxacin 0.3% is in Phase 3 clinical development. It is an investigational drug for bacterial conjunctivitis and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 985 participants, but the drug remains under clinical investigation.
Ofloxacin 0.3% has one completed Phase 3 clinical trial registered as NCT01573910. This study evaluated the safety and efficacy of moxifloxacin ophthalmic solution 0.5% versus ofloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in Chinese patients. The trial enrolled 985 participants and was active-controlled.
No, Ofloxacin 0.3% is not the same as moxifloxacin. They are different antibiotics. In the clinical trial NCT01573910, moxifloxacin ophthalmic solution 0.5% was compared against ofloxacin ophthalmic solution 0.3% as an active control. Both are fluoroquinolone antibiotics used for bacterial conjunctivitis, but they are distinct drug compounds.