NCT03709641已完成不适用
A Single-Arm, Single-Center, Randomized, Single-Masked Study to Evaluate Restylane Defyne for Canalicular Occlusion in Participants With Mild to Moderate Dry Eye Disease
John C Meyer, MD2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年10月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Evaluating change in Schirmer score from baseline
研究概览
简要总结
A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty-one (21) to 80 years of age
- •Baseline Ocular Surface Disease Index score of at least 13 with no more than 3 responses of "not applicable" for each eye individually
- •In the study eye, a baseline Schirmer test with anesthetic of ≤ 10 mm/5 minute
- •Literate, able to speak English and able to complete the questionnaire independently
- •Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
排除标准
- •Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day
- •History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery.
- •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, inhaled or topical ocular routes (dermatologic steroids not applied to the eyelids are allowed).
- •Participation in a clinical trial during the past 30 days
- •Women who are pregnant, planning a pregnancy, or nursing at study entry
研究组 & 干预措施
Restylane Defyne receiver
Experimental
Participants will receive Restyane Defyne injected into punctum of one eye.
干预措施: Restylane Defyne (Device)
结局指标
主要结局
Evaluating change in Schirmer score from baseline
时间窗: 42 days after screening visit
Maximum length of tears absorbed on test strips recorded.
次要结局
- Evaluating Tear break-up time (TBUT) from baseline.(42 days after screening visit)
- Evaluating change in corneal staining score from baseline.(42 days after screening visit)
- Evaluating change in Ocular Surface Disease index (OSDI) score from baseline(42 days after screening visit)
- Evaluating tear meniscus height from baseline.(42 days after screening visit.)
研究者
John C Meyer, MD
Ophthalmologist
The Eye Care Institute
研究点 (2)
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