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Trial record 26 of 52 for:    cataract AND ophthalmic suspension

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

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ClinicalTrials.gov Identifier: NCT01060072
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : January 13, 2012
Last Update Posted : January 13, 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: Loteprednol etabonate
Drug: Vehicle of Loteprednol Etabonate
Enrollment 407
Recruitment Details This study was conducted at 22 enrolling sites; 2 in the European Union (EU) and 20 in the United States (US). First participant was enrolled on 2/19/2010 and last participant completed the study on 9/3/2010.
Pre-assignment Details A total of 407 participants, who were candidates for routine, uncomplicated cataract surgery, were enrolled in the study, 400 participants completed the study.
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description Loteprednol etabonate 0.5% ophthalmic suspension Vehicle of loteprednol etabonate ophthalmic suspension.
Period Title: Overall Study
Started 206 201
Completed 204 196
Not Completed 2 5
Reason Not Completed
Adverse Event             1             1
Physician Decision             0             2
Protocol Violation             0             1
Acute cholecystitis             1             0
Excluded Medications             0             1
Arm/Group Title Loteprednol Etabonate Vehicle Total
Hide Arm/Group Description Loteprednol etabonate 0.5% ophthalmic suspension Vehicle of loteprednol etabonate ophthalmic suspension. Total of all reporting groups
Overall Number of Baseline Participants 206 201 407
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 201 participants 407 participants
68.3  (9.66) 69.4  (9.56) 68.9  (9.62)
[1]
Measure Description: Intent to treat Population (ITT)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 201 participants 407 participants
Female
124
  60.2%
109
  54.2%
233
  57.2%
Male
82
  39.8%
92
  45.8%
174
  42.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 206 participants 201 participants 407 participants
United States 198 193 391
Germany 8 8 16
1.Primary Outcome
Title Resolution of Anterior Chamber Cells.
Hide Description Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells
Time Frame Visit 5 (Postoperative day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description:
Loteprednol etabonate 0.5% ophthalmic suspension
Vehicle of loteprednol etabonate ophthalmic suspension.
Overall Number of Participants Analyzed 206 201
Measure Type: Number
Unit of Measure: participants
64 28
2.Primary Outcome
Title Grade 0 Pain
Hide Description Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
Time Frame Visit 5 (Postoperative day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description:
Loteprednol etabonate 0.5% ophthalmic suspension
Vehicle of loteprednol etabonate ophthalmic suspension.
Overall Number of Participants Analyzed 206 201
Measure Type: Number
Unit of Measure: participants
156 92
3.Secondary Outcome
Title Resolution of Anterior Chamber Cells
Hide Description Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells
Time Frame Visit 4-7 (postoperative day 3-18)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population (ITT)
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description:
Loteprednol etabonate 0.5% ophthalmic suspension
Vehicle of loteprednol etabonate ophthalmic suspension.
Overall Number of Participants Analyzed 206 201
Measure Type: Number
Unit of Measure: participants
Visit 4 (Postoperative Day 3) 8 7
Visit 5 (Postoperative Day 8) 64 28
Visit 6 (Postoperative Day 15) 116 61
Visit 7 (Postoperative Day 18) 114 59
4.Secondary Outcome
Title Grade 0 Pain
Hide Description Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Time Frame Visits 4-7 (Postoperative days 3-18)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population (ITT)
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description:
Loteprednol etabonate 0.5% ophthalmic suspension
Vehicle of loteprednol etabonate ophthalmic suspension.
Overall Number of Participants Analyzed 206 201
Measure Type: Number
Unit of Measure: participants
Visit 4 (Postoperative Day 3) 139 93
Visit 5 (Postoperative Day 8) 156 92
Visit 6 (Postoperative Day 15) 160 89
Visit 7 (Postoperative Day 18) 151 79
5.Secondary Outcome
Title Resolution of Anterior Chamber Flare
Hide Description Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.
Time Frame Visit 4-7 (postoperative day 3-18)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population (ITT)
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description:
Loteprednol etabonate 0.5% ophthalmic suspension
Vehicle of loteprednol etabonate ophthalmic suspension.
Overall Number of Participants Analyzed 206 201
Measure Type: Number
Unit of Measure: participants
Visit 4 (Postoperative Day 3) 93 64
Visit 5 (Postoperative Day 8) 134 72
Visit 6 (Postoperative Day 15) 162 90
Visit 7 (Postoperative Day 18) 143 75
Time Frame 14 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loteprednol Etabonate Vehicle
Hide Arm/Group Description Loteprednol etabonate 0.5% ophthalmic suspension Vehicle of loteprednol etabonate ophthalmic suspension.
All-Cause Mortality
Loteprednol Etabonate Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Loteprednol Etabonate Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/206 (1.46%)      1/201 (0.50%)    
Cardiac disorders     
Myocardial infarction  1  1/206 (0.49%)  1 0/201 (0.00%)  0
Gastrointestinal disorders     
Diverticulitis  1  1/206 (0.49%)  1 0/201 (0.00%)  0
Cholecystitis  1  1/206 (0.49%)  1 0/201 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/206 (0.00%)  0 1/201 (0.50%)  1
Hypokalemia  1  0/206 (0.00%)  0 1/201 (0.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Loteprednol Etabonate Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/206 (4.85%)      24/201 (11.94%)    
Eye disorders     
Anterior Chamber Inflammation  1  7/206 (3.40%)  7 14/201 (6.97%)  14
Eye Pain  1  3/206 (1.46%)  3 10/201 (4.98%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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: NCT01060072     History of Changes
Other Study ID Numbers: 577
First Submitted: January 29, 2010
First Posted: February 2, 2010
Results First Submitted: September 20, 2011
Results First Posted: January 13, 2012
Last Update Posted: January 13, 2012