NCT00824811

Brief Summary

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

First QC Date

January 16, 2009

Last Update Submit

August 1, 2012

Conditions

Epiphora

Keywords

EpiphoraBreast CancerLung CancerProstate CancerNon-small cell lung cancerBladder CancerEsophageal CancerHead and Neck CancerHNCSmall Cell Lung CancerSCLCOvarian CancerStomach CancerCanalicular StenosisExcessive tearingEye inflammationCyclosporine Ophthalmic Emulsion 0.05%DocetaxelTaxotereRestasis®CyclosporineCyclosporine eye dropsFML Forte®Fluorometholone 0.25% ophthalmic suspensionFluorometholone eye dropsFluorometholoneRefresh Endura™Lubricant eye dropsEye drops

Outcome Measures

Primary Outcomes (1)

  • Patient Epiphora Grade Scores

    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.

    Evaluated at Day 0 (Baseline) through Week 12

Study Arms (2)

Group 1: Cyclosporine eye drops

EXPERIMENTAL

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)Drug: Fluorometholone Eye Drops (FML Forte®)

Group 2: Lubricant Eye Drops

EXPERIMENTAL

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™)Drug: Fluorometholone Eye Drops (FML Forte®)

Interventions

Cyclosporine Eye Drops (Restasis)DRUG

One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.

Also known as: Cyclosporine eyedrops, Cyclosporine Opthalmic Emulsion 0.05%
Group 1: Cyclosporine eye drops
Lubricant Eye Drops (Refresh Endura™)DRUG

One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.

Also known as: Refresh Endura™ eye drops
Group 2: Lubricant Eye Drops
Fluorometholone Eye Drops (FML Forte®)DRUG

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®.

Also known as: Fluorometholone 0.25% Opthalmic Suspension
Group 1: Cyclosporine eye dropsGroup 2: Lubricant Eye Drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female subjects 18 years of age or older in good general health;
  • provide verbal and written informed consent as well as written release of health and study information;
  • 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;
  • 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;
  • experiencing symptoms of epiphora after receiving Docetaxel (Taxotere®) at the frequency of at least every 3 weeks for his/her cancer;
  • must have less than grade II canalicular stenosis on probing and irrigation at baseline;
  • following a prescribed course of Docetaxel (Taxotere®) and accommodating this course without excessive allergic reaction, nausea and/or other adverse reaction (mild or otherwise);
  • expected to remain on Docetaxel (Taxotere®) therapy for at least 4 weeks after enrollment in the study;
  • 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}
  • women of child bearing potential must have a negative urine pregnancy test at the screening visit and must not be lactating; and
  • willing and able to instill the study medications as directed, comply with study instructions and return to the clinic for required visits.

You may not qualify if:

  • experiencing excessive allergic reaction;
  • receiving any medications which may interfere with Docetaxel (Taxotere®) treatment for subject's cancer;
  • experiencing any concomitant disease which might interfere with the diagnosis and treatment of epiphora
  • 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;
  • anticipated contact lens wear during any portion of the study;
  • 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;
  • use of ocular ointments (including over-the-counter ointments) within one week of the baseline/screening visit;
  • used topical (including ophthalmic) or systemic cyclosporine within 90 days of the baseline/screening visit;
  • 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;
  • active ocular infection or inflammation in any eye;
  • active ocular allergy in any eye;
  • abnormal dilated fundus examination indicative of intraocular tumor presence;
  • corneal disorder or abnormality that affects cornea sensitivity or normal spreading of the tear film in any eye;
  • 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;
  • history of punctal occlusion, canalicular stenosis or nasolacrimal duct blockage.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Lacrimal Apparatus DiseasesBreast NeoplasmsLung NeoplasmsProstatic NeoplasmsCarcinoma, Non-Small-Cell LungUrinary Bladder NeoplasmsEsophageal NeoplasmsHead and Neck NeoplasmsSmall Cell Lung CarcinomaOvarian NeoplasmsStomach NeoplasmsLacerationsEndophthalmitis

Interventions

CyclosporinsLubricant Eye DropsFluorometholone

Condition Hierarchy (Ancestors)

Eye DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesCarcinoma, BronchogenicBronchial NeoplasmsUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersStomach DiseasesWounds and InjuriesEye InfectionsInfections

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of ChemicalsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, Fluorinated

Study Officials

  • Bita Esmaeli, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

June 1, 2009

Last Updated

August 2, 2012

Record last verified: 2012-08