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Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Primary Purpose

Ocular Inflammation

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

About this trial

This is an interventional treatment trial for Ocular Inflammation

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects at least 18 years of age
  • Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
  • Subjects who are candidate for routine, uncomplicated cataract surgery.
  • Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
  • Subjects must be willing and able to comply with all treatment and follow- up procedures.

Exclusion Criteria:

  • Subjects who have known hypersensitivity or contraindication to the study drug or its components.
  • Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
  • Subjects who have 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 (>/= 21 mm 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.
  • Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
  • Women who are pregnant or breast feeding.
  • Subjects who have participated in an investigational drug or device study within the last 30 days.
  • Subjects previously randomized in this study.

Sites / Locations

  • Cornerstone Eye Wear

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Loteprednol Etabonate

Vehicle

Arm Description

Loteprednol Etabonate 0.5%

Vehicle of Ophthalmic Loteprednol Etabonate

Outcomes

Primary Outcome Measures

Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Participants With Grade 0 (no) Pain
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe

Secondary Outcome Measures

Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.

Full Information

First Posted
June 13, 2008
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00699153
Brief Title
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Official Title
Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (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
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Loteprednol Etabonate
Arm Type
Experimental
Arm Description
Loteprednol Etabonate 0.5%
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of Ophthalmic Loteprednol Etabonate
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate
Intervention Description
Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Vehicle of Ophthalmic Loteprednol Etabonate
Intervention Description
Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.
Primary Outcome Measure Information:
Title
Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0
Description
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Time Frame
Postoperative day 8 (Visit 5)
Title
Participants With Grade 0 (no) Pain
Description
Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
Time Frame
Postoperative day 8 (Visit 5)
Secondary Outcome Measure Information:
Title
Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit.
Description
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Time Frame
At each visit: Visit 4-7, postoperative days 3-18
Title
Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare
Description
A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= >30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Time Frame
Postoperative Day 3-18 (Each follow-up Visit 4-7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects at least 18 years of age Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization. Subjects who are candidate for routine, uncomplicated cataract surgery. Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening. Subjects must be willing and able to comply with all treatment and follow- up procedures. Exclusion Criteria: Subjects who have known hypersensitivity or contraindication to the study drug or its components. Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study. Subjects who have 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 (>/= 21 mm 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. Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit. Women who are pregnant or breast feeding. Subjects who have participated in an investigational drug or device study within the last 30 days. Subjects previously randomized in this study.
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
Cornerstone Eye Wear
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

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Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

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