Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel

This study has been withdrawn prior to enrollment.
(Slow accrual.)
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00824811
First received: January 16, 2009
Last updated: August 1, 2012
Last verified: August 2012
  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 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient Epiphora Grade Scores [ Time Frame: Evaluated at Day 0 (Baseline) through Week 12 ] [ Designated as safety issue: No ]
    Epiphora score (how often dabbed tears, as recorded in a diary) assessed on a five-point scale to grade epiphora: 0: None; 1: Trace; 2: Mild; 3: Moderate; 4: Severe. It is evaluated at Day 0, Weeks 2, 4, 8 and 12. The within-arm comparison made between baseline (Day 0) and Week 4.


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.
Drug: Cyclosporine Eye Drops (Restasis)
One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.
Other Names:
  • Cyclosporine eyedrops
  • Cyclosporine Opthalmic Emulsion 0.05%
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
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

  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, Photorefractive keratectomy (PRK), Laser-Assisted Sub-Epithelial Keratectomy (or Laser Epithelial Keratomileusis) (LASEK/LASIK) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824811

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: 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 1, 2012
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

Additional relevant MeSH terms:
Docetaxel
Cyclosporins
Cyclosporine
Tetrahydrozoline
Ophthalmic Solutions
Fluorometholone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 16, 2014