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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Allergan |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00824811 |
Purpose
Objective:
To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®) treatment for various cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Epiphora |
Drug: Cyclosporine Eye Drops (Restasis) Drug: Lubricant Eye Drops (Refresh Endura™) Drug: Fluorometholone Eye Drops (FML Forte®) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Study Evaluating the Safety and Efficacy of Cyclosporine Ophthalmic Emulsion 0.05% [Restasis] in Subjects With Epiphora Secondary to Docetaxel [Taxotere] Treatment for Various Cancers |
| Enrollment: | 0 |
| Study Start Date: | June 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1: Cyclosporine eye drops
Cyclosporine Eye Drops (Restasis) 1 drop twice/day for 84 days to both eyes + Fluorometholone Eye Drops (FML Forte) on declining dose schedule.
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Drug: Cyclosporine Eye Drops (Restasis)
One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.
Other Names:
Drug: Fluorometholone Eye Drops (FML Forte®)
Week 1: One drop four times a day to both eyes. Week 2: One drop three times a day to both eyes. Week 3: One drop twice a day to both eyes. Week 4: One drop once a day to both eyes. Wait at least 10 minutes after Restasis® or Refresh Endura™ instillation to instill FML Forte®. Other Name: Fluorometholone 0.25% Opthalmic Suspension
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Experimental: Group 2: Lubricant Eye Drops
Lubricant Eye Drops (Refresh Endura) 1 drop twice/day for 84 days to both eyes + Fluorometholone Eye Drops (FML Forte) on declining dose schedule.
|
Drug: Lubricant Eye Drops (Refresh Endura™)
One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.
Other Name: Refresh Endura™ eye drops
Drug: Fluorometholone Eye Drops (FML Forte®)
Week 1: One drop four times a day to both eyes. Week 2: One drop three times a day to both eyes. Week 3: One drop twice a day to both eyes. Week 4: One drop once a day to both eyes. Wait at least 10 minutes after Restasis® or Refresh Endura™ instillation to instill FML Forte®. Other Name: Fluorometholone 0.25% Opthalmic Suspension
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Bita Esmaeli, MD/Associate Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00824811 History of Changes |
| Other Study ID Numbers: | 2007-0757 |
| Study First Received: | January 16, 2009 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Epiphora Breast Cancer Lung Cancer Prostate Cancer Non-small cell lung cancer Bladder Cancer Esophageal Cancer Head and Neck Cancer HNC Small Cell Lung Cancer SCLC Ovarian Cancer Stomach Cancer Canalicular Stenosis Excessive tearing |
Eye inflammation Cyclosporine Ophthalmic Emulsion 0.05% Docetaxel Taxotere Restasis® Cyclosporine Cyclosporine eye drops FML Forte® Fluorometholone 0.25% ophthalmic suspension Fluorometholone eye drops Fluorometholone Refresh Endura™ Lubricant eye drops Eye drops |
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Lacrimal Apparatus Diseases Eye Diseases Cyclosporins Cyclosporine Tetrahydrozoline Fluorometholone Docetaxel Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents |
Therapeutic Uses Dermatologic Agents Antirheumatic Agents Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Respiratory System Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Allergic Agents |