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Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis

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ClinicalTrials.gov Identifier: NCT01478256
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : November 20, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
George John, M.D., John, George, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Blepharitis
Interventions Drug: Erythromycin
Drug: Besifloxocin
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Besifloxocin Erythromycin
Hide Arm/Group Description Use of topical besifloxocin twice a day to treat acute blepharitis Topical Erythromycin ointment twice a day for treatment of acute blepharitis
Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Besifloxocin Erythromycin Total
Hide Arm/Group Description Use of topical besifloxocin twice a day to treat acute blepharitis Topical Erythromycin ointment twice a day for treatment of acute blepharitis Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  66.7%
10
  66.7%
20
  66.7%
>=65 years
5
  33.3%
5
  33.3%
10
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
48  (10) 50  (12) 49  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
8
  53.3%
7
  46.7%
15
  50.0%
Male
7
  46.7%
8
  53.3%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Improvement in Signs and Symptoms of Blepharitis
Hide Description Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics
Time Frame Four weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Besifloxocin Erythromycin
Hide Arm/Group Description:
Use of topical besifloxocin to treat acute blepharitis
Topical Erythromycin ointment for treatment of acute blepharitis
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
15 15
2.Secondary Outcome
Title Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics
Hide Description Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis
Time Frame Three weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Besifloxocin Erythromycin
Hide Arm/Group Description:
Use of topical besifloxocin twice a day to treat acute blepharitis
Topical Erythromycin ointment twice a day for treatment of acute blepharitis
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
15 15
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Besifloxocin Erythromycin
Hide Arm/Group Description Use of topical besifloxocin to treat acute blepharitis Topical Erythromycin ointment for treatment of acute blepharitis
All-Cause Mortality
Besifloxocin Erythromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Besifloxocin Erythromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Besifloxocin Erythromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (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: George John
Organization: George John MD
Phone: 5028949757
EMail: grjohn777@yahoo.com
Layout table for additonal information
Responsible Party: George John, M.D., John, George, M.D.
ClinicalTrials.gov Identifier: NCT01478256     History of Changes
Other Study ID Numbers: SAIRB-11-0007
First Submitted: November 21, 2011
First Posted: November 23, 2011
Results First Submitted: April 9, 2013
Results First Posted: November 20, 2013
Last Update Posted: December 19, 2013