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Trial record 38 of 506 for:    MOXIFLOXACIN

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

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ClinicalTrials.gov Identifier: NCT01573910
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: Moxifloxacin ophthalmic solution, 0.5%
Drug: Ofloxacin ophthalmic solution, 0.3%
Enrollment 985
Recruitment Details Participants were recruited from 16 study centers located in China.
Pre-assignment Details Of the 985 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (982).
Arm/Group Title Moxifloxacin Ofloxacin
Hide Arm/Group Description 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Period Title: Overall Study
Started 489 493
Completed 469 476
Not Completed 20 17
Reason Not Completed
Adverse Event             4             4
Lost to Follow-up             2             1
Withdrawal by Subject             0             1
Protocol Violation             3             0
Patient decision unrelated to Advs Event             11             11
Arm/Group Title Moxifloxacin Ofloxacin Total
Hide Arm/Group Description 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 Total of all reporting groups
Overall Number of Baseline Participants 489 493 982
Hide Baseline Analysis Population Description
This analysis population includes all participants who were administered study medication or potentially used study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 489 participants 493 participants 982 participants
37.4  (15.54) 38.4  (15.83) 37.9  (15.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 489 participants 493 participants 982 participants
Female
254
  51.9%
265
  53.8%
519
  52.9%
Male
235
  48.1%
228
  46.2%
463
  47.1%
1.Primary Outcome
Title Clinical Cure Rate
Hide Description 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.
Time Frame Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Ofloxacin
Hide Arm/Group Description:
1 drop instilled TID in each eye for 7 days with a TOC at Day 9
1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Overall Number of Participants Analyzed 295 291
Measure Type: Number
Unit of Measure: percentage of participants
85.4 81.4
2.Primary Outcome
Title Microbiological Success Rate
Hide Description 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.
Time Frame Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Ofloxacin
Hide Arm/Group Description:
1 drop instilled TID in each eye for 7 days with a TOC at Day 9
1 drop instilled TID in each eye for 7 days with a TOC at Day 9
Overall Number of Participants Analyzed 295 291
Measure Type: Number
Unit of Measure: percentage of participants
95.3 94.8
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Moxifloxacin Ofloxacin
Hide Arm/Group Description 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 1 drop instilled TID in each eye for 7 days with a TOC at Day 9
All-Cause Mortality
Moxifloxacin Ofloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin Ofloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/489 (0.20%)   0/493 (0.00%) 
Vascular disorders     
Hypertension  1  1/489 (0.20%)  0/493 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin Ofloxacin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/489 (0.00%)   0/493 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Firoz Vohra, Project Head, Pharma
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01573910     History of Changes
Other Study ID Numbers: C-10-051
First Submitted: April 6, 2012
First Posted: April 10, 2012
Results First Submitted: April 27, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015