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Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Primary Purpose

Dry Eye Disease, Ocular Comfort

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bromfenac
ketorolac
Sponsored by
Florida Eye Microsurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Must be in general good health
  • Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

  • Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
  • Patients who are pregnant or nursing females
  • Unwilling to discontinue use of contact lenses during the run-in and duration of the study
  • Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
  • Previous treatment failure on CSA 0.05% (Restasis)
  • Known hypersensitivity to any component of the study or procedural medications
  • Participation in any other clinical trial within 30 days prior to screening
  • Known contraindication to any study medication or any of their components.
  • Should not be taking any oral anti-histamines, beta blockers or diuretics.

Sites / Locations

  • Florida Eye Microsurgical Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Active treatment arm bromfenac 0.09% BID for 6 weeks

ketorolac 0.4% BID for 6 weeks

Outcomes

Primary Outcome Measures

Ocular comfort

Secondary Outcome Measures

Full Information

First Posted
August 21, 2007
Last Updated
February 17, 2009
Sponsor
Florida Eye Microsurgical Institute
Collaborators
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00520260
Brief Title
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
Official Title
Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Florida Eye Microsurgical Institute
Collaborators
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease, Ocular Comfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Active treatment arm bromfenac 0.09% BID for 6 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
ketorolac 0.4% BID for 6 weeks
Intervention Type
Drug
Intervention Name(s)
bromfenac
Intervention Description
0.09%, BID, 6 weeks
Intervention Type
Drug
Intervention Name(s)
ketorolac
Intervention Description
0.4%, BID, 6 weeks
Primary Outcome Measure Information:
Title
Ocular comfort
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be in general good health Diagnosis of moderate to severe dry eye syndrome Exclusion Criteria: Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy Patients who are pregnant or nursing females Unwilling to discontinue use of contact lenses during the run-in and duration of the study Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye Previous treatment failure on CSA 0.05% (Restasis) Known hypersensitivity to any component of the study or procedural medications Participation in any other clinical trial within 30 days prior to screening Known contraindication to any study medication or any of their components. Should not be taking any oral anti-histamines, beta blockers or diuretics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Schechter, MD
Organizational Affiliation
Florida Eye Microsurgical Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States

12. IPD Sharing Statement

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Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

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