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Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

Primary Purpose

Ocular Inflammation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.5% Loteprednol Etabonate Ophthalmic Ointment
Vehicle of Loteprednol Etabonate Ophthalmic Ointment
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:

  1. Subjects who are candidate for routine, uncomplicated cataract surgery
  2. 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:

  1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
  2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
  3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
  4. Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit

Sites / Locations

  • John Hunkeler, MD

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 ointment

Vehicle of loteprednol etabonate ointment

Outcomes

Primary Outcome Measures

Subjects 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.
Grade 0 for 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

Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up 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.
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
March 13, 2008
Last Updated
March 4, 2015
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00645671
Brief Title
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
Official Title
A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus 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
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 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
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. 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% ophthalmic ointment
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of loteprednol etabonate ointment
Intervention Type
Drug
Intervention Name(s)
0.5% Loteprednol Etabonate Ophthalmic Ointment
Intervention Description
1/2 inch ribbon four times a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Vehicle of Loteprednol Etabonate Ophthalmic Ointment
Intervention Description
1/2 inch ribbon four times a day for 14 days
Primary Outcome Measure Information:
Title
Subjects 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
Grade 0 for 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
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up 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 follow-up visit through day18 (Visit 7)
Title
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
Baseline and each follow-up visit through day18 (Visit 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who are candidate 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 will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson J Berliner, MD/PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
John Hunkeler, MD
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States

12. IPD Sharing Statement

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Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

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