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Trial record 5 of 5 for:    "Blepharitis" | "Anti-Allergic Agents"

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

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ClinicalTrials.gov Identifier: NCT01028027
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : September 15, 2011
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Conjunctivitis
Keratitis
Blepharitis
Interventions Drug: Loteprednol and tobramycin
Drug: Tobramycin and dexamethasone
Enrollment 357
Recruitment Details This study was conducted at seven sites, by seven Investigators in the People’s Republic of China. First participant was enrolled 10/21/2009 and last participant visit was 2/9/2010.
Pre-assignment Details A total of 357 participants with clinically diagnosed blepharokeratoconjunctivitis (BKC) in at least one eye were enrolled. 328 participants completed the study.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days. Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Period Title: Overall Study
Started 180 177
Completed 164 164
Not Completed 16 13
Reason Not Completed
Lost to Follow-up             4             1
Withdrawal by Subject             5             3
Adverse Event             4             7
Protocol Violation             3             1
Lack of Efficacy             0             1
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone Total
Hide Arm/Group Description Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days. Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days. Total of all reporting groups
Overall Number of Baseline Participants 180 177 357
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 177 participants 357 participants
40.8  (13.63) 41.72  (13.54) 41.26  (13.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 177 participants 357 participants
Female
123
  68.3%
113
  63.8%
236
  66.1%
Male
57
  31.7%
64
  36.2%
121
  33.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Singapore Number Analyzed 180 participants 177 participants 357 participants
180 177 357
1.Primary Outcome
Title Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Hide Description The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was the population used for the primary efficacy analysis.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description:
Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Number of Participants Analyzed 156 152
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-11.63  (4.56) -12.41  (4.71)
2.Secondary Outcome
Title Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
Hide Description The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Time Frame Baseline, Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used in this secondary efficacy parameter.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description:
Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Number of Participants Analyzed 164 165
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-11.64  (4.55) -11.98  (4.95)
3.Secondary Outcome
Title Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
Hide Description The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was used for this secondary efficacy parameters.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description:
Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Number of Participants Analyzed 155 150
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-9.20  (3.94) -10.21  (4.23)
4.Secondary Outcome
Title Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
Hide Description The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Time Frame Baseline, Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used in this secondary efficacy parameter.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description:
Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Number of Participants Analyzed 172 171
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-8.91  (4.24) -9.96  (4.27)
5.Secondary Outcome
Title Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
Hide Description The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.
Time Frame Baseline, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population was used for this secondary efficacy parameters.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description:
Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Number of Participants Analyzed 155 152
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-5.66  (3.46) -5.98  (3.68)
6.Secondary Outcome
Title Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
Hide Description The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.
Time Frame Baseline, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was used for this secondary efficacy parameters.
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description:
Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
Overall Number of Participants Analyzed 177 176
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-5.54  (3.48) -5.92  (3.69)
Time Frame 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loteprednol and Tobramycin Tobramycin and Dexamethasone
Hide Arm/Group Description Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days. Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
All-Cause Mortality
Loteprednol and Tobramycin Tobramycin and Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Loteprednol and Tobramycin Tobramycin and Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/177 (0.00%)      0/177 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Loteprednol and Tobramycin Tobramycin and Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/177 (9.04%)      36/177 (20.34%)    
Eye disorders     
Increased IOP  1 [1]  16/177 (9.04%)  52 36/177 (20.34%)  52
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
Overall IOP change from baseline >5mmHg
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.
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tuyen Ong, MD
Organization: Bausch & Lomb Incorporated
Phone: (973) 360-6389
EMail: tuyen.ong@bausch.com
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01028027     History of Changes
Other Study ID Numbers: 617
First Submitted: December 8, 2009
First Posted: December 9, 2009
Results First Submitted: July 14, 2011
Results First Posted: September 15, 2011
Last Update Posted: February 28, 2012