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OpenTrials
Completed

NCT Number: NCT00520260

Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

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

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Ocular Comfort

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bromfenac

Drug

0.09%, BID, 6 weeks

Ketorolac

Drug

0.4%, BID, 6 weeks

Primary outcomes

  1. Ocular comfort

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Florida Eye Microsurgical Institute

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Official study title

Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 23, 2007
Registry last updated
Feb 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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