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

Primary Purpose

Inflammation, Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vehicle of Loteprednol Etabonate
Loteprednol Etabonate
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Loteprednol Etabonate

Vehicle

Arm Description

Loteprednol etabonate

Vehicle of loteprednol etabonate

Outcomes

Primary Outcome Measures

Resolution of Anterior Chamber Cells (ACC).
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
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.

Secondary Outcome Measures

Resolution of Anterior Chamber Cells.
Study eyes with complete resolution of anterior chamber cells (ACC)

Full Information

First Posted
November 6, 2009
Last Updated
December 8, 2011
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01010633
Brief Title
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loteprednol Etabonate
Arm Type
Experimental
Arm Description
Loteprednol etabonate
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of loteprednol etabonate
Intervention Type
Drug
Intervention Name(s)
Vehicle of Loteprednol Etabonate
Intervention Description
1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate
Intervention Description
1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
Primary Outcome Measure Information:
Title
Resolution of Anterior Chamber Cells (ACC).
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)
Title
Grade 0 Pain
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)
Secondary Outcome Measure Information:
Title
Resolution of Anterior Chamber Cells.
Description
Study eyes with complete resolution of anterior chamber cells (ACC)
Time Frame
At visits 4-7- postoperative day 3, 8,15 & 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Trusso
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24136301
Citation
Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.
Results Reference
derived

Learn more about this trial

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

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