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Moxifloxacin vs. Polytrim for Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00581542
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Frank Gigliotti, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Conjunctivitis
Interventions Drug: moxifloxacin
Drug: polytrim
Enrollment 124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polytrim Group Moxifloxin Group
Hide Arm/Group Description Randomization to polytrim : 1-2 drops four times a day for 8-10 days. Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
Period Title: Overall Study
Started 62 62
Completed 51 39
Not Completed 11 23
Reason Not Completed
they met an exclusion criteria             2             2
Lost to Follow-up             9             21
Arm/Group Title Polytrim Ophthalmic Solution Moxifloxacin Ophthalmic Solution Total
Hide Arm/Group Description randomization to topical polytrim randomization to topical moxifloxacin Total of all reporting groups
Overall Number of Baseline Participants 62 62 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 62 participants 62 participants 124 participants
73.4  (50) 70.3  (48) 71.3  (49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 124 participants
Female
39
  62.9%
28
  45.2%
67
  54.0%
Male
23
  37.1%
34
  54.8%
57
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants 62 participants 124 participants
62 62 124
1.Primary Outcome
Title Number of Participants With Normal Physical Examination of the Eye
Hide Description [Not Specified]
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polytrim Arm Moxifloxacin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 51 39
Measure Type: Number
Unit of Measure: participants
49 37
2.Secondary Outcome
Title Number of Participants With a Negative Bacterial Culture
Hide Description Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group.
Arm/Group Title Moxifloxin Group Polytrim Group
Hide Arm/Group Description:
Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
Overall Number of Participants Analyzed 28 31
Measure Type: Number
Unit of Measure: participants
22 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin Treatment Group Polytrim Treatment Group
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Moxifloxacin Treatment Group Polytrim Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Moxifloxacin Treatment Group Polytrim Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/62 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Moxifloxacin Treatment Group Polytrim Treatment Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/62 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Franci Gigilotti
Organization: University of Rochester, Strong Mem orial Hospital
Phone: 585 275-0588
EMail: francis_gigilotti@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Frank Gigliotti, University of Rochester
ClinicalTrials.gov Identifier: NCT00581542    
Other Study ID Numbers: RSRB #17454
First Submitted: December 18, 2007
First Posted: December 27, 2007
Results First Submitted: April 15, 2015
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016