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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammation Pain | Drug: Vehicle of Loteprednol Etabonate Drug: Loteprednol Etabonate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 406 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Loteprednol Etabonate
Loteprednol etabonate
|
Drug: 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
|
Drug: Vehicle of Loteprednol Etabonate
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
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- 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.
- 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.
- 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010633
United States, New York | |
Bausch & Lomb, Inc. | |
Rochester, New York, United States, 14609 |
Study Director: | Laura Trusso | Bausch & Lomb Incorporated |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT01010633 History of Changes |
Other Study ID Numbers: |
576 |
First Posted: | November 10, 2009 Key Record Dates |
Results First Posted: | January 9, 2012 |
Last Update Posted: | January 9, 2012 |
Last Verified: | December 2011 |
Additional relevant MeSH terms:
Inflammation Pathologic Processes Loteprednol Etabonate Anti-Allergic Agents |