Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel (NCT00824811) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient Epiphora Grade Scores
Timeframe: Evaluated at Day 0 (Baseline) through Week 12
. 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;