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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Patient Epiphora Grade Scores
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •unable to cannulate the puncta (grade 3 on the Canalicular Stenosis Scale);
- •unable to successfully irrigate the canaliculi;
- •Schirmer's Test - Standard Test (with anesthesia) result of </= 3 mm;
- •epiphora is due to reflex tearing resulting from dry eye syndrome;
- •history of anterior segment surgery or trauma in either eye which would affect corneal sensitivity (e.g., cataract surgery, Photorefractive keratectomy (PRK), Laser-Assisted Sub-Epithelial Keratectomy (or Laser Epithelial Keratomileusis) (LASEK/LASIK) or any surgery involving a limbal or corneal incision) within the last 12 months;
- •current use, use within 2 weeks prior to Day 0 (baseline) or likely to use during the study period of any topical ophthalmic medications (e.g., antibiotics, glaucoma medications) other than ophthalmic medications used in this study;
- •known allergy or hypersensitivity to Restasis® (cyclosporine A) and its excipients and/or FML Forte® (Fluorometholone 0.25%) and its excipients;
- •requirement for concomitant procedure(s)/therapy that would interfere with study objectives must cease use at least 4 weeks prior to enrollment and remain free from use of these procedures/therapies throughout duration of this study;
- •pregnant, nursing, or planning a pregnancy during the course of the study and females of childbearing potential, not using a reliable means of contraception;
- •clinically diagnosed by the investigator to have none to trace epiphora [grades 0 or 1on a five-point scale (0-4)] in either eye;
- •history of allergy or sensitivity to the other medications used in this study (Refresh Endura™) or their excipients;
- •history of herpetic eye disease;
- •any condition or situation which, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
研究组 & 干预措施
Group 1: Cyclosporine eye drops
Cyclosporine Eye Drops (Restasis) 1 drop twice/day for 84 days to both eyes + Fluorometholone Eye Drops (FML Forte) on declining dose schedule.
干预措施: Cyclosporine Eye Drops (Restasis) (Drug)
Group 1: Cyclosporine eye drops
Cyclosporine Eye Drops (Restasis) 1 drop twice/day for 84 days to both eyes + Fluorometholone Eye Drops (FML Forte) on declining dose schedule.
干预措施: Fluorometholone Eye Drops (FML Forte®) (Drug)
Group 2: Lubricant Eye Drops
Lubricant Eye Drops (Refresh Endura) 1 drop twice/day for 84 days to both eyes + Fluorometholone Eye Drops (FML Forte) on declining dose schedule.
干预措施: Lubricant Eye Drops (Refresh Endura™) (Drug)
Group 2: Lubricant Eye Drops
Lubricant Eye Drops (Refresh Endura) 1 drop twice/day for 84 days to both eyes + Fluorometholone Eye Drops (FML Forte) on declining dose schedule.
干预措施: Fluorometholone Eye Drops (FML Forte®) (Drug)
结局指标
主要结局
Patient Epiphora Grade Scores
时间窗: 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.
次要结局
未报告次要终点