Clinical Trial: Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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.


Detailed Summary:

The Study Drugs:

Restasis® is also known as cyclosporine ophthalmic emulsion 0.05% (cyclosporine eye drops). It is designed to decrease eye inflammation.

FML Forte® is also known as fluorometholone 0.25% ophthalmic suspension (fluorometholone eye drops). It is designed to decrease eye inflammation. Fluorometholone eye drops are commonly used to help to control epiphora.

In this study, an additional type of eye drops will be used for comparison with cyclosporine eye drops. This second type of eye drops is called Refresh Endura™ (lubricant eye drops), which is designed to relieve dry eyes. Unlike cyclosporine and fluorometholone, it does not have active ingredients designed to treat epiphora.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 groups. The way of assigning participants to groups is mostly random, as in the flip of a coin. However, your epiphora score (how often you dabbed your tears, as recorded in a diary) will also affect what group you are assigned to.

Group 1 will receive cyclosporine eye drops and fluorometholone eye drops. Group 2 will receive lubricant eye drops and fluorometholone eye drops.

Neither you nor the study staff will know whether you are receiving cyclosporine eye drops or lubricant eye drops. However, if needed for your safety, the study staff will be able to find out which one you are receiving.

Study Drug Administration Your first dose of the study drugs will be given in the clinic on Day 1. After that, you will give yourself
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Patient Epiphora Grade Scores [ Time Frame: Evaluated at Day 0 (Baseline) through Week 12 ]

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.


Original Primary Outcome: 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 ]

Current Secondary Outcome:

Original Secondary Outcome: Restasis® plus FML Forte® will be compared to Restasis® plus Refresh Endura™. [ Time Frame: 2 Years ]

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: January 16, 2009
Date Started: June 2009
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012