Safety, Tolerability, Plug Retention and Preliminary Efficacy of Tacrolimus-loaded Punctal Plug in Patients With Moderate to Severe Dry Eye Disease - Cohort B
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Eximore Ltd.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary safety endpoint is adverse events' frequency, severity, and duration.
研究概览
简要总结
The purpose of this interventional study is to assess safety, patient tolerability, plug retention rate, and preliminary efficacy in improving the symptoms of Dry Eye Disease (DED) of EXP-TC tacrolimus releasing punctal plug. The main questions it aims to answer are:
- The safety of using EXP-TC plug following all study adverse events
- The number of patients with Adverse Events related to the us of EXP-LP plug
- The number of patients discontinuing the study due to plug discomfort
- The total patients with plugs remained during the 3-months study duration from plug insertion
- Exploratory: change from baseline in the study eye to follow-up visits in various Dryness clinical measurements. The change of measurements from baseline will also be compared between the study and fellow control eye (receiving artificial tears only, 0.15% sodium hyaluronate).
详细描述
Device Description - EXP-TC punctual plug is a delivery system for Tacrolimus- an immunosuppressive macrolide drug that is has been proved to improve Dry-Eye Disease (DED) symptoms, similar to and sometimes better than the well-known cyclosporine. The EXP-TC punctual plug is designed for insertion into the punctual opening. The plug is molded of a medical-grade composite containing Tacrolimus. The plug design features a flattened head/rim which remains outside the punctum and a central neck/shaft which tapers outward toward a nose. The plug is designed to create a vector force to keep the plug snugly in the punctual opening. As soon as the tears wet the plug, the drug is locally released. The plug has Pangolin design with 3 different sizes, Small, Medium and Big.
The commercial lubricant (positive study control) preservative-free, 0.15% sodium hyaluronate (Hyabak) is marketed by, Théa laboratories and is known as a common first-line treatment for DED
Study Design - This is a prospective, single center, open-label, self-controlled ("split body" design) non-randomized single eye study performed on patients with moderate to severe dry eye disease.
Study Population and Justification - Up to 20 patients with DED in both eyes will be enrolled. Due to early feasibility stage of the study, no formal sample size calculation was done for this study.
The intent to treat (ITT) population, defined as enrolled participants not including those who leave the study prematurely during the screening period (before EXP-TC insertion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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, 18 years of age and over;
- •Patient-reported history of DED in both eyes
- •Use of artificial tears within 3 months before the Screening Visit
- •Corneal fluorescein staining score ≥2 (0- to 4-point scale) in ≥1 region (superior, inferior, or central) in at least one eye
- •Schirmer ≥1 and ≤10 mm in both eyes
- •Central corneal thickness of 400-620 microns.
- •IOP ≤ 24 mmHg in each eye
排除标准
- •Intolerance or contraindication to Tacrolimus
- •Stevens-Johnson Syndrome;
- •Use of methotrexate or systemic cyclosporine within the 3 months before the Screening Visit;
- •Using systemic anti-rheumatic therapy, if started within 6 months before recruitment OR that the systemic disease is considered unstable OR that the patient is unsure of continuing using the treatment throughout the current study;
- •Use of any anti-rheumatic biological agent within 2 months, or 5 half-lives, whichever is longer, before the Screening Visit;
- •Use of oral corticosteroids >10 mg prednisone, or equivalent, per day, if started within 2 months before screening;
- •Use of topical steroids within 4 weeks before the Screening Visit and for the duration of the study
- •Use of oral statin or preparation containing omega-3 fatty acid unless dose has been stable for at least 3 months and will remain so during the trial;
- •Presence of chronic ocular disease other than Aqueous-Deficient Dry Eye requiring topical treatment.
- •Presence of post-burn ocular injury;
- •Active ocular herpes simplex virus infection;
- •Concomitant use of contact lenses or use within 3 months before the Screening Visit or inability to abstain from contact lens use throughout the study.
- •Persistent intraocular inflammation or infection;
- •Have anterior blepharitis, which is deemed clinically significant and likely to interfere with study parameters in the opinion of the investigator;
- •Meibomian gland dysfunction (MGD) necessitating treatment in the 4 weeks before or planned during the study period.
- •Surgical occlusion of the lacrimal puncta, including the insertion of punctual plugs, within 3 months of the Screening
- •Continuous cough OR fever/high temperature (38.0oC or greater) OR loss of/change in the sense of smell or taste (anosmia).
- •Recent ocular or eyelid surgery
- •Pregnant women or women suspected of being pregnant, nursing mothers
- •Inability to abstain from any topical ocular treatments other than unpreserved artificial tears for the duration of the trial
- •Use of autologous serum eye drops (ASED) if started within 2 weeks before the Screening Visit
研究组 & 干预措施
EXP-TC punctal plug together with artificial tears
EXP-TC: A punctal plug as a delivery system for Tacrolimus. EXP-TC has 3 different sizes (Small, Medium and Big for Wide EXP-TC)
干预措施: punctum plug insertion (Device)
EXP-TC punctal plug together with artificial tears
EXP-TC: A punctal plug as a delivery system for Tacrolimus. EXP-TC has 3 different sizes (Small, Medium and Big for Wide EXP-TC)
干预措施: Eye Drops, Lubricant (Drug)
Artificial tears
Preservative-free, 0.15% sodium hyaluronate (Hyabak, Théa laboratories)
干预措施: Eye Drops, Lubricant (Drug)
结局指标
主要结局
The primary safety endpoint is adverse events' frequency, severity, and duration.
时间窗: Will be evaluated through study completion (6 weeks)
Main Adverse Event that will be focused on during the study: Irritation and local discomfort Increased Lacrimation Increased mucus Intraocular inflammation Ocular redness Eyelid Edema Hyperemia conjunctival erythema Keratitis
The number of Participants with Treatment-Related Adverse Events
时间窗: Will be evaluated through study completion (6 weeks)
as assessed by CTCAE v4.0
次要结局
- Patient Tolerability(Will be evaluated through study completion (6 weeks))
- Exploratory Endpoint3(Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion))
- Exploratory Endpoint5(Will be evaluated from baseline to termination visit (6 weeks from plug insertion))
- Exploratory Endpoint6(Will be evaluated from baseline to termination visit (6 weeks from plug insertion))
- Exploratory Endpoint7(Will be evaluated from baseline to termination visit (6 weeks from plug insertion))
- Plug retention rate(Study termination visit: 6 weeks after plug insertion)
- Exploratory Endpoint1(Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion))
- Exploratory Endpoint2(Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion))
- Exploratory Endpoint4(Will be evaluated from baseline to follow up visit 6 (4 weeks from plug insertion))
- Exploratory Endpoint8(Will be evaluated from baseline to termination visit (6 weeks from plug insertion))