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Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00698724
First Posted: June 17, 2008
Last Update Posted: June 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bp Consulting, Inc
  Purpose
To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

Condition Intervention Phase
Cataracts Drug: Xibrom, and Optive Drug: Xibrom and Pred Forte Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

Resource links provided by NLM:


Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • OCT [ Time Frame: 2-4 months ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 2-4 months ]

Estimated Enrollment: 200
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Group 1: Xibrom, Optive
Drug: Xibrom, and Optive
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
Active Comparator: 2
Group 2: Xibrom, Pred Forte
Drug: Xibrom and Pred Forte
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female at least 18 years of age.

    • Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
    • Patients should be in good general health and devoid of recognized risk factors for CME.
    • Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
    • Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
    • Only one eye of each treated patient may be included in the study

Exclusion Criteria:

  • Any known contraindications to any study medication or their component
  • Presence of uncontrolled systemic disease
  • Required use of other ocular medications during the study

    o Artificial tears may be used

  • Diabetics with any clinically evident or history of retinopathy
  • Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
  • Abnormal pre-operative OCT (if obtainable)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698724


Locations
United States, Florida
St. Luke's Cataract and Laser institute
Tarpon Springs, Florida, United States, 34688
Sponsors and Collaborators
Bp Consulting, Inc
Investigators
Principal Investigator: James Gills, MD St. Luke's Cataract and Laser Institute
  More Information

Responsible Party: Dr. Gills, St. Luke's Cataract and Laser Institute
ClinicalTrials.gov Identifier: NCT00698724     History of Changes
Other Study ID Numbers: 5359
First Submitted: June 13, 2008
First Posted: June 17, 2008
Last Update Posted: June 10, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Prednisolone acetate
Methylprednisolone acetate
Bromfenac
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Pharmaceutical Solutions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents