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Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

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ClinicalTrials.gov Identifier: NCT00759148
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : March 22, 2011
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Other: Moxifloxacin AF Vehicle
Enrollment 1179
Recruitment Details Subjects were recruited from 108 study centers located in the US.
Pre-assignment Details 1179 subjects with bacterial conjunctivitis were randomized and treated to Moxifloxacin AF or Moxifloxacin AF vehicle.
Arm/Group Title Moxifloxacin AF Vehicle
Hide Arm/Group Description Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Period Title: Overall Study
Started 593 586
Completed 579 554
Not Completed 14 32
Reason Not Completed
Adverse Event             1             6
Withdrawal by Subject             3             7
Lost to Follow-up             3             9
Treatment Failure             6             10
Reason not given             1             0
Arm/Group Title Moxifloxacin AF Vehicle Total
Hide Arm/Group Description Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days Moxifloxacin AF Vehicle, 1 drop in each eye twice daily for 3 days Total of all reporting groups
Overall Number of Baseline Participants 593 586 1179
Hide Baseline Analysis Population Description
This population analysis includes all subjects who received study drug (Safety Analysis Set).
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 593 participants 586 participants 1179 participants
Infants and toddlers (28 days-23 months)
49
   8.3%
47
   8.0%
96
   8.1%
Children (2-11 years)
174
  29.3%
184
  31.4%
358
  30.4%
Adolescents (12-17 years)
71
  12.0%
72
  12.3%
143
  12.1%
Adults (18-64 years)
257
  43.3%
230
  39.2%
487
  41.3%
From 65-84 years
38
   6.4%
48
   8.2%
86
   7.3%
85 years and over
4
   0.7%
5
   0.9%
9
   0.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 593 participants 586 participants 1179 participants
Female
353
  59.5%
338
  57.7%
691
  58.6%
Male
240
  40.5%
248
  42.3%
488
  41.4%
1.Primary Outcome
Title Clinical Cure at the Day 4 (EOT)/Exit Visit
Hide Description 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.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set).
Arm/Group Title Moxifloxacin AF Vehicle
Hide Arm/Group Description:
Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Overall Number of Participants Analyzed 424 423
Measure Type: Number
Unit of Measure: percentage of subjects
62.5 50.6
2.Secondary Outcome
Title Microbiological Success at the Day 4 (EOT)/Exit Visit
Hide Description Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
MBITT Analysis Set
Arm/Group Title Moxifloxacin AF Vehicle
Hide Arm/Group Description:
Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Overall Number of Participants Analyzed 424 423
Measure Type: Number
Unit of Measure: percentage of subjects
74.5 56
Time Frame Baseline through study completion, an average of 4 days
Adverse Event Reporting Description An AE was defined as any untoward change (expected or unexpected) in a patient’s ophthalmic and/or medical health that occurred after initiation of study treatment. AEs were obtained as solicited comments from the study patient/guardian and as observations by the study investigator.
 
Arm/Group Title Moxifloxacin AF Vehicle
Hide Arm/Group Description Subjects exposed to Moxifloxacin AF Subjects exposed to Moxifloxacin AF Vehicle
All-Cause Mortality
Moxifloxacin AF Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/593 (0.00%)   0/586 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin AF Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/593 (0.00%)   0/586 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin AF Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/593 (0.00%)   0/586 (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 to review study related information prior to presentation or publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Lead
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: NCT00759148     History of Changes
Other Study ID Numbers: C-07-40
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: February 23, 2011
Results First Posted: March 22, 2011
Last Update Posted: January 2, 2018