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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Allergan |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00824811 |
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 |
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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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Cyclosporine Eye Drops (Restasis) + Fluorometholone Eye Drops (FML Forte)
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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.
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®. |
Group 2: Experimental
Lubricant Eye Drops (Refresh Endura) + Fluorometholone Eye Drops (FML Forte)
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Drug: Lubricant Eye Drops (Refresh Endura™)
One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.
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®. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bita Esmaeli Esmaeli, MD | 713-792-6920 |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Bita Esmaeli, MD | M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Bita Esmaeli, MD/Associate Professor ) |
Study ID Numbers: | 2007-0757 |
Study First Received: | January 16, 2009 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00824811 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Anti-Inflammatory Agents Fluorometholone Cyclosporine Immunologic Factors Clotrimazole Hormone Antagonists Miconazole Esophageal Neoplasms Hormones, Hormone Substitutes, and Hormone Antagonists Lacrimal Apparatus Diseases Constriction, Pathologic Tetrahydrozoline Hormones Cyclosporins Nasal Decongestants |
Docetaxel Phenylephrine Lung Neoplasms Antifungal Agents Stomach Neoplasms Vasoconstrictor Agents Neoplasm Metastasis Ovarian Cancer Bladder Neoplasm Pseudoephedrine Ovarian Neoplasms Eye Diseases Tioconazole Urinary Bladder Neoplasms Breast Neoplasms |
Anti-Inflammatory Agents Fluorometholone Anti-Infective Agents Respiratory System Agents Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Lacrimal Apparatus Diseases Tetrahydrozoline Hormones Cyclosporins Nasal Decongestants |
Docetaxel Antifungal Agents Therapeutic Uses Vasoconstrictor Agents Dermatologic Agents Sympathomimetics Eye Diseases Enzyme Inhibitors Anti-Allergic Agents Cardiovascular Agents Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents |