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Evaluation of 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
Loteprednol etabonate
Vehicle of 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.

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 visual acuity (VA) 20/200 or worse in the non-study eye.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Loteprednol etabonate

Vehicle

Arm Description

Loteprednol etabonate 0.5% ophthalmic suspension

Vehicle of loteprednol etabonate ophthalmic suspension

Outcomes

Primary Outcome Measures

Resolution of Anterior Chamber Cells.
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
Grade 0 Pain
Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain

Secondary Outcome Measures

Resolution of Anterior Chamber Cells
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
Grade 0 Pain
Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain
Resolution of Anterior Chamber Flare
Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.

Full Information

First Posted
January 29, 2010
Last Updated
December 8, 2011
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01060072
Brief Title
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Official Title
A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% 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
February 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 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 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
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loteprednol etabonate
Arm Type
Experimental
Arm Description
Loteprednol etabonate 0.5% ophthalmic suspension
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of loteprednol etabonate ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Loteprednol etabonate
Intervention Description
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
Intervention Type
Drug
Intervention Name(s)
Vehicle of Loteprednol Etabonate
Intervention Description
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.
Primary Outcome Measure Information:
Title
Resolution of Anterior Chamber Cells.
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)
Title
Grade 0 Pain
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)
Secondary Outcome Measure Information:
Title
Resolution of Anterior Chamber Cells
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)
Title
Grade 0 Pain
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)
Title
Resolution of Anterior Chamber Flare
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)

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. 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 visual acuity (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
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

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

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