Prospective Multicenter, Randomized, Double-Masked, Controlled Trial to Evaluate Clinical Utility and Safety of the Visant Medical Canalicular Device in Subjects Who Are Candidates for Occlusion With Punctal or Canalicular Plugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 10
- 主要终点
- Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug
研究概览
简要总结
This study is designed to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug.
详细描述
The objective of this study is to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug over 6 months of subject follow-up.
Study subjects who are eligible for enrollment and have provided written informed consent will be randomized in a 2:1 ratio (i.e., 2 subjects randomized to the Visant Medical Canalicular Plug for every 1 subject randomized to a commercially available canalicular plug). All study subjects will be treated bilaterally with plugs placed in the inferior canaliculi.
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, Outcomes Assessor)
盲法说明
Subjects will be masked to their assignment to either the treatment or control group. Clinical personnel who perform clinical assessments will also be masked to the subjects' assignment to either the treatment or control group ("masked evaluators"). The eye care professional who inserts the test and control devices will not be masked and will not be eligible to perform follow-up evaluations.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Twenty-two (22) years of age or older
- •BCDVA of 20/40 or better in each eye
- •Both eyes with a baseline Schirmer's test with anesthetic ≤ 10 mm/5 minutes
- •Presence of corneal staining in both eyes in any of the 5 areas defined by the NEI/Industry Workshop Scale
- •Baseline OSDI score of at least 23 with no more than 3 responses of "not applicable"
- •Patent bilateral lacrimal drainage system as demonstrated by punctal irrigation
- •If female, subject must be post-menopausal, medically sterile (e.g hysterectomy, bilateral tubal ligation, bilateral oophorectomy) or have negative urine pregnancy test (UPT) on Day 0 of the study and agree to utilize a medically acceptable form of contraception over the course of the study
- •Willing and able to sign informed consent and HIPAA authorization, follow study instructions, and complete all study visits.
排除标准
- •Use of ophthalmic cyclosporine (Restasis) within 6 months or lifitegrast (Xiidra) within 3 months prior to Day 0 in either eye
- •History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery in either eye
- •Corneal transplant in either eye
- •Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit
- •A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease)
- •The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer
- •Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring treatment (i.e., antihistamines, decongestants, oral or aerosol steroids)
- •Use of steroids, including administration by systemic or topical ocular routes (dermatologic steroids not applied to the eyelids and inhaled steroids are allowed)
- •Participation in a clinical trial during the past 30 days
- •Women who are pregnant, planning a pregnancy, or nursing at study entry
结局指标
主要结局
Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug
时间窗: 3 months
Non-inferiority hypothesis. Higher Score using this continuous variable equates to larger tear film
次要结局
- Mean change in tear meniscus height from baseline(Month 6)
- Mean change in corneal staining score from baseline (NEI workshop scale)(Month 6)
- Mean change in tear break up time from baseline(Month 6)
- Proportion of responders achieving improvement from Baseline in Ocular Surface Disease Index (OSDI) score by a Minimal Clinically Important Difference (MCID).(3 months)
- Mean change in OSDI score from baseline(Month 6)
- Mean change in Schirmer score from baseline(Month 6)