Prospective, Randomized, Masked, Controlled Trial To Evaluate The Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 14
- 主要终点
- Tear Break-Up Time
研究概览
简要总结
To demonstrate the safety and effectiveness of TearCare® procedures compared to Restasis® to treat the signs and symptoms of dry eye disease in adult patients.
详细描述
In this prospective, multicenter, randomized, active-controlled trial, TearCare is compared to cyclosporine 0.05% ophthalmic emulsion (Restasis) in eyes with dry eye disease (DED). Subjects randomized to TearCare receive TearCare treatment at baseline and Month 5, while subjects randomized to Restasis dose twice-daily with Restasis from baseline through Month 6. Primary inference is based on outcomes at the Month 6 visit including the co-primary endpoints tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 22 years of age
- •Reports dry eye symptoms within the past 3 to 6 months
- •Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms.
- •Schirmer tear test (with anesthesia) ≥1 to ≤10 mm in 5 minutes
- •OSDI Score of 23-79
- •TBUT of ≥1 to ≤7 seconds in both eyes
- •Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
- •At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
- •Best corrected visual acuity of 20/100 or better in both eyes.
- •Willing and able to comply with the study procedures and follow-up
- •Willing and able to provide informed consent
- •English-speaking
排除标准
- •Use of any of the following medications:
- •Cyclosporine (Restasis, Cequa etc.) or Xiidra within 60 days prior to enrollment;
- •Antihistamines (oral or topical) within 10 days prior to enrollment;
- •Systemic medication(s) (other than antihistamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial;
- •Accutane (at any time);
- •Oral tetracyclines or azithromycin within 30 days prior to enrollment; or
- •Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti- inflammatory medications within 30 days prior to enrollment.
- •Any of the following dry eye treatments:
- •Office-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation [Lipiflow], iLux etc.) within 12 months prior to enrollment either as part of routine care or clinical investigation;
- •Meibomian gland expression within 6 months prior to enrollment;
- •Blephex or debridement within 3 months prior to enrollment is an exclusion;
- •Punctal occlusion or punctal plugs. Investigators can choose to remove the punctal plugs 15 days prior to enrollment;
- •Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or
- •Any history of meibomian gland probing
- •History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
- •Contact lens use within the past 2 weeks.
- •History of Ocular Herpes Simplex or Ocular Herpes Zoster
- •Any active, clinically significant ocular or peri-ocular infection or inflammation
- •Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment
- •Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
- •Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
- •Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
研究组 & 干预措施
TearCare Group (Study Device) (Baseline to Month 24)
TearCare System
干预措施: TearCare System (Device)
Restasis Group (Control) (Baseline to Month 6)
Restasis® (0.05% Cyclosporine ophthalmic emulsion).
干预措施: Cyclosporine Ophthalmic 0.05% Ophthalmic Emulsion (Drug)
Restasis group crossed over to TearCare (Month 6 to Month 12)
Subjects originally randomized to Restasis stop Restasis use at Month 6 and receive a single TearCare treatment at Month 6 and are then followed through Month 12.
干预措施: TearCare System (Device)
结局指标
主要结局
Tear Break-Up Time
时间窗: 6 months
Change in Tear Break-Up Time (TBUT) from baseline to month 6
OSDI Score
时间窗: 6 months
Change in Ocular Surface Disease Index (OSDI) score from baseline to 6-months. The OSDI is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 6 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.
次要结局
未报告次要终点