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Sponsored by: |
Bp Consulting, Inc |
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Information provided by: | Bp Consulting, Inc |
ClinicalTrials.gov Identifier: | NCT00698724 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment |
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 |
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 |
---|---|
1: Active Comparator
Group 1: Xibrom, Optive
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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.
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2: Active Comparator
Group 2: Xibrom, Pred Forte
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male or female at least 18 years of age.
Exclusion Criteria:
Required use of other ocular medications during the study
United States, Florida | |
St. Luke's Cataract and Laser institute | |
Tarpon Springs, Florida, United States, 34688 |
Principal Investigator: | James Gills, MD | St. Luke's Cataract and Laser Institute |
Responsible Party: | St. Luke's Cataract and Laser Institute ( Dr. Gills ) |
Study ID Numbers: | 5359 |
Study First Received: | June 13, 2008 |
Last Updated: | June 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00698724 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Methylprednisolone Hormone Antagonists Eye Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Methylprednisolone acetate Lens Diseases Prednisolone acetate Neuroprotective Agents |
Glucocorticoids Hormones Bromfenac Analgesics, Non-Narcotic Cataract Prednisolone Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Methylprednisolone Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Lens Diseases Hormones Neuroprotective Agents Sensory System Agents Therapeutic Uses Cataract Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Eye Diseases Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Pharmacologic Actions Bromfenac Analgesics, Non-Narcotic Autonomic Agents Prednisolone Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |