WithdrawnPhase 2

Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel

Stopped: Slow accrual.

0Started 2009-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

Patient Epiphora Grade Scores

Timeframe: Evaluated at Day 0 (Baseline) through Week 12

Trial details

NCT IDNCT00824811

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

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