- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010633
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
December 8, 2011 updated by: Bausch & Lomb Incorporated
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
406
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14609
- Bausch & Lomb, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who are at least 18 years of age.
- Subjects who are candidates for routine, uncomplicated cataract surgery.
- Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
Exclusion Criteria:
- Subjects who have known hypersensitivity or contraindication to the study drug or components.
- Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
- Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
- Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Loteprednol Etabonate
Loteprednol etabonate
|
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
|
Placebo Comparator: Vehicle
Vehicle of loteprednol etabonate
|
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of Anterior Chamber Cells (ACC).
Time Frame: Visit 5 (Postoperative day 8)
|
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.
|
Visit 5 (Postoperative day 8)
|
Grade 0 Pain
Time Frame: Visit 5 (Postoperative Day 8)
|
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.
|
Visit 5 (Postoperative Day 8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resolution of Anterior Chamber Cells.
Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18
|
Study eyes with complete resolution of anterior chamber cells (ACC)
|
At visits 4-7- postoperative day 3, 8,15 & 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Laura Trusso, Bausch & Lomb Incorporated
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
November 6, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Estimate)
January 9, 2012
Last Update Submitted That Met QC Criteria
December 8, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 576
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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