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Moxifloxacin Alternative Formulation 0.5%

Phase 3

Bacterial Conjunctivitis | Small molecule | Infectious Disease |Alcon Inc.|Last Updated: Jan 2, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,874

FDA Designations

No designations recorded

Clinical trial landscape

Moxifloxacin Alternative Formulation 0.5% · 2 trials · 1 indication

Phase 3 2
NCT00759148Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial ConjunctivitisBacterial Conjunctivitis
COMPLETED1,179 Analytics
NCT00332293AL-15469A for the Treatment of Bacterial ConjunctivitisBacterial Conjunctivitis
COMPLETED695 Analytics
PHASE3COMPLETED
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Bacterial ConjunctivitisUnlock trial analytics
PHASE3COMPLETED
AL-15469A for the Treatment of Bacterial Conjunctivitis
Bacterial ConjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Cure at the Day 4 (EOT)/Exit Visit
Day 4

Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.

Clinical cure and microbiological success

Secondary Endpoints

Microbiological Success at the Day 4 (EOT)/Exit Visit
Day 4
Individual signs and symptoms of bacterial conjunctivitis at each visit
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Moxifloxacin AFEXPERIMENTALMoxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
VehiclePLACEBO_COMPARATORMoxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
MoxifloxacinEXPERIMENTAL -
VIGAMOXACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%DRUGEye drops
Moxifloxacin AF VehicleOTHERInactive ingredients used as a placebo for masking purposes
Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%DRUG1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
Moxifloxacin hydrochloride ophthalmic solution 0.5% as baseDRUG1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
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Eligibility Criteria

Age Range1 Month to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosed with bacterial conjunctivitis in 1 or both eyes; * Able to understand and sign an informed consent form. If subject is \<18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative; * Agrees to comply with th...

Countries:United States
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