To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery...
Date First Received: January 7, 2008
Last Updated: January 15, 2008
Verified by: Bp Consulting, Inc, January 2008
Clinical Trial Phase: Phase 4 | Start Date: January 2008
Overall Status: Recruiting
Estimated Enrollment: 166
Brief Summary
Condition Keyword(s):
Intervention(s):
To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Study Primary Completion Date: May 2008
Intervention(s) in this Clinical Trial
- Drug: Bromfenac
- 1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
- Drug: Ketorolac
- 1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
- Drug: Diclofenac
- 1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Comparator: 2
- Active Comparator: 3
Outcome Measures for this Clinical Trial
Primary Measures
- Acute Pseudophakic Cystoid Macular Edema
- Time Frame: 5 months
Safety Issue?: No
- Time Frame: 5 months
Secondary Measures
- Visual Acuity
- Time Frame: 5 months
Safety Issue?: No
- Time Frame: 5 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
- Males and females 18 years and older
- Able to provide written informed consent
Exclusion Criteria:
- Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
- Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
- History of Uveitis
- Ipsilateral intraocular surgery prior to cataract surgery
- CME greater than one year duration
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bp Consulting, Inc
Overall Clinical Trial Officials and Contacts
David Rho, MD Principal Investigator Soll Eye Associates
Overall Contact: Michelle Chabot 714-246-9581 michelle_bpconsulting@yahoo.com
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00595543
Study ID Number: 5349
ClinicalTrials.gov Identifier: NCT00595543
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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