Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel
|First Received Date ICMJE||January 16, 2009|
|Last Updated Date||August 1, 2012|
|Start Date ICMJE||June 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE
||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 ] [ Designated as safety issue: Yes ]|
|Change History||Complete list of historical versions of study NCT00824811 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE
||Restasis® plus FML Forte® will be compared to Restasis® plus Refresh Endura™. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel|
|Official Title ICMJE||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|
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.
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.
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 the rest of the doses at home. The study staff will teach you how to use the eye drops, and you will be given written instructions. Study data will be collected on both eyes, and you will apply the drops to both eyes.
If you wear contact lenses, be sure to take your contact lenses out before using the eye drops. Fifteen (15) minutes after your dose of the eye drops, you may put your contact lenses back in.
If you are in Group 1, you will apply 1 drop of cyclosporine eye drops to each eye, 2 times a day, for 84 days (12 weeks) in a row. You should wait about 12 hours between doses.
If you are in Group 2, you will apply 1 drop of lubricant eye drops to each eye, 2 times a day, for 84 days in a row. You should wait about 12 hours between doses.
All study participants must wait at least 10 minutes after you have applied your other eye drops (cyclosporine or the lubricant) before you can apply the fluorometholone eye drops.
All study participants will receive fluorometholone eye drops. During Week 1, you will apply 1 drop to each eye, 4 times a day. During Week 2, you will apply 1 drop to each eye, 3 times a day. During Week 3, you will apply 1 drop to each eye, 2 times a day. During Week 4, you will apply 1 drop to each eye, once a day.
On Visit 1 (Day -1 or -2), your eye doctor and/or study staff will ask you to sign the written informed consent. Screening tests will be done, which include urine pregnancy test for all women who are able to become pregnant, and other eye exams, such as Best Corrected Visual Acuity, Biomicroscopy, Intraocular Pressure (IOP), Epiphora Assessments, Schirmer's Test, and Probing and Irrigation Test. Your eye doctor and/or assistant will explain these different eye exams, or any questions you may have, at the day of your visit. You will also be asked about the different medications that you are currently taking. You will be given participant diaries for you to record or keep track of your medication use and how many times you dab your tears. You will then be given the schedule of your next visit.
On Visit 2 (Day 0 or baseline), the study staff will record how well you tolerate the study drugs and any side effects that may occur after the doses. You will also complete 2 questionnaires. The first questionnaire asks about the quality of your life and the second questionnaire asks about any problems with your vision that you may be experiencing. In total, they should take about 10-15 minutes to complete.
You will be given additional patient diaries. In the first diary, you will record any missed doses of the study drugs. In the second diary, you will record how many times you dab tears from your eyes and/or face, starting 24 hours before each clinic visit.
You should bring the completed patient diaries and the used containers of the study drugs with you to every study visit.
At Weeks 2, 4, and 8, the following procedures will be performed:
Length of Study Participation:
You may stay on study treatment for up to 12 weeks. If intolerable side effects occur, or the epiphora gets worse and the study doctor thinks you should consider surgery to treat it, you will be taken off study treatment early.
After your last dose of the study drugs (at Week 12, or earlier if you go off study treatment early), you will return for an end-of-study visit. At this visit, the following procedures will be performed:
THIS IS AN INVESTIGATIONAL STUDY. Cyclosporine eye drops, fluorometholone eye drops, and Refresh Endura™ lubricant eye drops are commercially available for other eye conditions. They are not FDA approved for use in treating epiphora. At this time and for this purpose, they are considered experimental. This includes fluorometholone eye drops, which are commonly used to treat epiphora but are not FDA approved for this use.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00824811|
|Other Study ID Numbers ICMJE||2007-0757|
|Has Data Monitoring Committee||Yes|
|Responsible Party||M.D. Anderson Cancer Center|
|Study Sponsor ICMJE||M.D. Anderson Cancer Center|
|Information Provided By||M.D. Anderson Cancer Center|
|Verification Date||August 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP