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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:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00698724
First received: June 13, 2008
Last updated: June 8, 2009
Last verified: June 2009
History of Changes
  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 Blind (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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • OCT [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Gills, St. Luke's Cataract and Laser Institute
ClinicalTrials.gov Identifier: NCT00698724     History of Changes
Other Study ID Numbers: 5359
Study First Received: June 13, 2008
Last Updated: June 8, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013