- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992355
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
October 8, 2009 updated by: Veroia General Hospital
Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial
This randomized controlled trial compares two regimens of topical therapy:
- tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
- combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day. The topical treatment is administered for 28 days after phacoemulsification.
Patients are independently assessed by two ophthalmologists. On day 28, patients are evaluated for
- corneal edema
- conjunctival redness
- anterior chamber reaction. Moreover, the cases necessitating continuation of treatment are compared in the two groups on day 28 and 42.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
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
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-
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Veroia, Greece, 59100
- Department of Ophthalmology, Veroia General Hospital
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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
55 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Phacoemulsification (due to cataract)
- Uneventful phacoemulsification surgery
Exclusion Criteria:
- Disruption of the anterior lens capsule
- Age-related macular degeneration
- Proliferative diabetic retinopathy
- Glaucoma
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tobramycin 0.3% - Dexamethasone 0.1%
|
|
Active Comparator: Tobramycin-Dexamethasone plus Ketorolac tromethamine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
October 8, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Estimate)
October 9, 2009
Last Update Submitted That Met QC Criteria
October 8, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Lens Diseases
- Cataract
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Anti-Bacterial Agents
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Ketorolac
- Tobramycin
- Ketorolac Tromethamine
Other Study ID Numbers
- VGH-EYE01
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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