NCT00520260

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

1 year

First QC Date

August 21, 2007

Last Update Submit

February 17, 2009

Conditions

Dry Eye DiseaseOcular Comfort

Outcome Measures

Primary Outcomes (1)

  • Ocular comfort

    six weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Active treatment arm bromfenac 0.09% BID for 6 weeks

Drug: bromfenac

2

ACTIVE COMPARATOR

ketorolac 0.4% BID for 6 weeks

Drug: ketorolac

Interventions

bromfenacDRUG

0.09%, BID, 6 weeks

1
ketorolacDRUG

0.4%, BID, 6 weeks

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

bromfenacKetorolac

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Barry Schechter, MD

    Florida Eye Microsurgical Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

US(1)