Trial Outcomes & Findings for An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients (NCT NCT01573910)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

985 participants

Primary outcome timeframe

Day 9

Results posted on

2015-05-12

Participant Flow

Participants were recruited from 16 study centers located in China.

Of the 985 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (982).

Participant milestones

Participant milestones
Measure	Moxifloxacin 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Ofloxacin 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Overall Study STARTED	489	493
Overall Study COMPLETED	469	476
Overall Study NOT COMPLETED	20	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Moxifloxacin 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Ofloxacin 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Overall Study Adverse Event	4	4
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	0	1
Overall Study Protocol Violation	3	0
Overall Study Patient decision unrelated to Advs Event	11	11

Baseline Characteristics

An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moxifloxacin n=489 Participants 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Ofloxacin n=493 Participants 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Total n=982 Participants Total of all reporting groups
Age, Continuous	37.4 years STANDARD_DEVIATION 15.54 • n=93 Participants	38.4 years STANDARD_DEVIATION 15.83 • n=4 Participants	37.9 years STANDARD_DEVIATION 15.69 • n=27 Participants
Sex: Female, Male Female	254 Participants n=93 Participants	265 Participants n=4 Participants	519 Participants n=27 Participants
Sex: Female, Male Male	235 Participants n=93 Participants	228 Participants n=4 Participants	463 Participants n=27 Participants

PRIMARY outcome

Timeframe: Day 9

Population: This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.

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.

Outcome measures

Outcome measures
Measure	Moxifloxacin n=295 Participants 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Ofloxacin n=291 Participants 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Clinical Cure Rate	85.4 percentage of participants	81.4 percentage of participants

PRIMARY outcome

Timeframe: Day 9

Population: This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.

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.

Outcome measures

Outcome measures
Measure	Moxifloxacin n=295 Participants 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Ofloxacin n=291 Participants 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Microbiological Success Rate	95.3 percentage of participants	94.8 percentage of participants

Adverse Events

Moxifloxacin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Ofloxacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Moxifloxacin n=489 participants at risk 1 drop instilled TID in each eye for 7 days with a TOC at Day 9	Ofloxacin n=493 participants at risk 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Vascular disorders Hypertension	0.20% 1/489 • Adverse events (AEs) were collected for the duration of the study (May 2012 to April 2014). This analysis group includes all patients who were administered or potentially used study medication. An adverse event was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment.	0.00% 0/493 • Adverse events (AEs) were collected for the duration of the study (May 2012 to April 2014). This analysis group includes all patients who were administered or potentially used study medication. An adverse event was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment.

Other adverse events

Adverse event data not reported

Additional Information

Firoz Vohra, Project Head, Pharma

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER