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Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel
This study is not yet open for participant recruitment.
Verified by M.D. Anderson Cancer Center, January 2009
First Received: January 16, 2009   Last Updated: January 20, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
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

Genetics Home Reference related topics: bladder cancer breast cancer
MedlinePlus related topics: Cancer
Drug Information available for: Cyclosporine Cyclosporin Tetrahydrozoline Docetaxel Fluorometholone Tetrahydrozoline hydrochloride Fluorometholone acetate
U.S. FDA Resources
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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study if Restasis® in combination with FML Forte® can help to control epiphora that may have been caused by taking docetaxel to treat cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Restasis® plus FML Forte® will be compared to Restasis® plus Refresh Endura™. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

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
Group 1: Experimental
Cyclosporine Eye Drops (Restasis) + Fluorometholone Eye Drops (FML Forte)
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)
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®.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. male or female subjects 18 years of age or older in good general health;
  2. provide verbal and written informed consent as well as written release of health and study information;
  3. clinically diagnosed by the investigator to have mild to severe epiphora [grades 2, 3 or 4 on a five-point scale (0-4)] in one or both eyes;
  4. diagnosed with any of the following types of cancer: breast, non-small cell lung, prostate, bladder, esophageal, head and neck, small cell lung, ovarian and stomach;
  5. experiencing symptoms of epiphora after receiving Docetaxel (Taxotere®) at the frequency of at least every 3 weeks for his/her cancer;
  6. must have less than grade II canalicular stenosis on probing and irrigation at baseline;
  7. following a prescribed course of Docetaxel (Taxotere®) and accommodating this course without excessive allergic reaction, nausea and/or other adverse reaction (mild or otherwise);
  8. expected to remain on Docetaxel (Taxotere®) therapy for at least 4 weeks after enrollment in the study;
  9. women of childbearing potential must be willing to practice effective contraception for the duration of the study (i.e. abstinence, spermicide, condoms, or birth control pills [BCP]); {NOTE: Females on birth control pills (BCP) must be stable on the same type and dose of pill for at least three months prior to entering the study and must not change the type of BCP or dosing regimen during the study. Those who have used BCPs in the past must have discontinued usage at least 3 months prior to the start of the study}
  10. women of child bearing potential must have a negative urine pregnancy test at the screening visit and must not be lactating; and
  11. willing and able to instill the study medications as directed, comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

  1. experiencing excessive allergic reaction;
  2. receiving any medications which may interfere with Docetaxel (Taxotere®) treatment for subject's cancer;
  3. experiencing any concomitant disease which might interfere with the diagnosis and treatment of epiphora
  4. changed their hormone replacement or deprivation therapy (i.e., estrogen replacement or estrogen and androgen deprivation) program within three months of the baseline/screening visit or anticipate starting such a program during the course of the study;
  5. anticipated contact lens wear during any portion of the study;
  6. changed their treatment regimen of beta blocking agents, or cholinergic agonists within three months of the baseline/screening visit or anticipate changing, starting, or ending such a regimen during the course of the study;
  7. use of ocular ointments (including over-the-counter ointments) within one week of the baseline/screening visit;
  8. used topical (including ophthalmic) or systemic cyclosporine within 90 days of the baseline/screening visit;
  9. diagnosed with acne rosacea and currently on any systemic tetracycline antibiotic or any other prescribed treatment such as metronidazole, or have used any prescribed treatment for acne rosacea in the past;
  10. active ocular infection or inflammation in any eye;
  11. active ocular allergy in any eye;
  12. abnormal dilated fundus examination indicative of intraocular tumor presence;
  13. corneal disorder or abnormality that affects cornea sensitivity or normal spreading of the tear film in any eye;
  14. severe blepharitis or obvious inflammation of the lid margin in any eye which, in the judgment of the investigator, may interfere with the interpretation of the study results;
  15. history of punctal occlusion, canalicular stenosis or nasolacrimal duct blockage.
  16. unable to cannulate the puncta (grade 3 on the Canalicular Stenosis Scale);
  17. unable to successfully irrigate the canaliculi;
  18. Schirmer's Test - Standard Test (with anesthesia) result of </= 3 mm;
  19. epiphora is due to reflex tearing resulting from dry eye syndrome;
  20. history of anterior segment surgery or trauma in either eye which would affect corneal sensitivity (e.g., cataract surgery, LASIK, PRK or any surgery involving a limbal or corneal incision) within the last 12 months;
  21. current use, use within 2 weeks prior to Day 0 (baseline) or likely to use during the study period of any topical ophthalmic medications (e.g., antibiotics, glaucoma medications) other than ophthalmic medications used in this study;
  22. known allergy or hypersensitivity to Restasis® (cyclosporine A) and its excipients and/or FML Forte® (Fluorometholone 0.25%) and its excipients;
  23. requirement for concomitant procedure(s)/therapy that would interfere with study objectives must cease use at least 4 weeks prior to enrollment and remain free from use of these procedures/therapies throughout duration of this study;
  24. pregnant, nursing, or planning a pregnancy during the course of the study and females of childbearing potential, not using a reliable means of contraception;
  25. clinically diagnosed by the investigator to have none to trace epiphora [grades 0 or 1on a five-point scale (0-4)] in either eye;
  26. history of allergy or sensitivity to the other medications used in this study (Refresh Endura™) or their excipients;
  27. history of herpetic eye disease;
  28. any condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824811

Contacts
Contact: Bita Esmaeli Esmaeli, MD 713-792-6920

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Allergan
Investigators
Principal Investigator: Bita Esmaeli, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009