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Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

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ClinicalTrials.gov Identifier: NCT01010633
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : January 9, 2012
Last Update Posted : January 9, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Inflammation
Pain
Interventions Drug: Vehicle of Loteprednol Etabonate
Drug: Loteprednol Etabonate
Enrollment 406
Recruitment Details This study was initiated at 20 clinics in the United States (US). Three sites did not enroll any participants. The study was conducted at the remaining 17 sites. First participant was enrolled 11/23/2009 and last participant completed 6/25/2010.
Pre-assignment Details 406 participants eligible for cataract surgery were enrolled in the study (safety population). 397 participants completed the study.
Arm/Group Title Loteprednol Vehicle
Hide Arm/Group Description Loteprednol etabonate 0.5% Vehicle of loteprednol etabonate
Period Title: Overall Study
Started 203 203
Completed 199 198
Not Completed 4 5
Reason Not Completed
Adverse Event             1             1
Protocol Violation             1             2
Withdrawal by Subject             2             1
Investigator decision             0             1
Arm/Group Title Loteprednol Vehicle Total
Hide Arm/Group Description Loteprednol etabonate 0.5% Vehicle of loteprednol etabonate Total of all reporting groups
Overall Number of Baseline Participants 203 203 406
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 203 participants 406 participants
69.3  (8.73) 69.0  (9.80) 69.1  (9.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 203 participants 406 participants
Female
109
  53.7%
122
  60.1%
231
  56.9%
Male
94
  46.3%
81
  39.9%
175
  43.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 203 participants 203 participants 406 participants
American Indian or Alaska Native 0 1 1
Asian 2 3 5
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 20 16 36
White 176 182 358
Other 4 1 5
1.Primary Outcome
Title Resolution of Anterior Chamber Cells (ACC).
Hide Description Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Time Frame Visit 5 (Postoperative day 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population
Arm/Group Title Loteprednol Vehicle
Hide Arm/Group Description:
Loteprednol Etabonate 0.5%
Vehicle of Loteprednol Etabonate
Overall Number of Participants Analyzed 203 203
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
203 203
Measure Type: Number
Unit of Measure: Eyes
62 33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loteprednol, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.3
Confidence Interval (2-Sided) 95%
5.7 to 22.9
Estimation Comments [Not Specified]
2.Primary Outcome
Title Grade 0 Pain
Hide Description Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
Time Frame Visit 5 (Postoperative Day 8)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (ITT)
Arm/Group Title Loteprednol Vehicle
Hide Arm/Group Description:
Loteprednol Etabonate 0.5%
Vehicle of Loteprednol Etabonate
Overall Number of Participants Analyzed 203 203
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
203 203
Measure Type: Number
Unit of Measure: Eyes
148 85
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Loteprednol, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.0
Confidence Interval (2-Sided) 95%
21.4 to 40.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Resolution of Anterior Chamber Cells.
Hide Description Study eyes with complete resolution of anterior chamber cells (ACC)
Time Frame At visits 4-7- postoperative day 3, 8,15 & 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loteprednol Vehicle
Hide Arm/Group Description:
Loteprednol Etabonate 0.5%
Vehicle of Loteprednol Etabonate
Overall Number of Participants Analyzed 203 203
Measure Type: Number
Unit of Measure: Eyes
Visit 4 17 11
Visit 5 62 33
Visit 6 102 44
Visit 7 96 45
Time Frame Visit 3 post-operative day 1 thru visit 7 postoperative day 18
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loteprednol Vehicle
Hide Arm/Group Description Loteprednol etabonate 0.5% Vehicle of loteprednol etabonate
All-Cause Mortality
Loteprednol Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Loteprednol Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/203 (0.49%)      2/203 (0.99%)    
Cardiac disorders     
Heart Failure  1 [1]  0/203 (0.00%)  0 1/203 (0.49%)  1
Eye disorders     
Cystoid Macular Edema  1 [2]  1/203 (0.49%)  1 1/203 (0.49%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchitis  1 [3]  0/203 (0.00%)  0 1/203 (0.49%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
SAEs were unrelated to study drug
[2]
Unrelated to study drug, but probably related to study procedure
[3]
The event is serious, unexpected, unrelated to the study drug and the study procedure but rather possibly related to a concomitant illness in a predisposed patient
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Loteprednol Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/203 (0.00%)      0/203 (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.
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
Name/Title: Tuyen Ong, MD, MRCOphth
Organization: Bausch & Lomb Incorporated
Phone: (973) 360-6389
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01010633     History of Changes
Other Study ID Numbers: 576
First Submitted: November 6, 2009
First Posted: November 10, 2009
Results First Submitted: August 30, 2011
Results First Posted: January 9, 2012
Last Update Posted: January 9, 2012