- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00698724
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
June 8, 2009 updated by: Bp Consulting, Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tarpon Springs, Florida, United States, 34688
- St. Luke's Cataract and Laser Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Group 1: Xibrom, 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
OCT
Time Frame: 2-4 months
|
2-4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Acuity
Time Frame: 2-4 months
|
2-4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Gills, MD, St. Luke's Cataract and Laser Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 13, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Estimate)
June 10, 2009
Last Update Submitted That Met QC Criteria
June 8, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lens Diseases
- Cataract
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Bromfenac
Other Study ID Numbers
- 5359
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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