NCT06309953已完成4 期
An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 7
- 主要终点
- Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3
研究概览
简要总结
An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
详细描述
The primary objective of this study is to evaluate early outcomes with Miebo treatment in subjects with Dry Eye Disease (DED)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •At least 18 years of age at the time of consent
- •Able to provide written voluntary informed consent
- •The same eye must satisfy the below inclusion criteria (a-e):
- •Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1
- •Tear-film break-up time ≤5 seconds at Visit 1
- •Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute scale at Visit 1
- •Total meibomian gland dysfunction score ≥3 (range, 0-15)
- •Unanesthetized Schirmer's test I score ≥5 mm
- •Ocular Surface Disease Index (OSDI) ≥25 at Visit 1
- •Able and willing to follow instructions, including participation in all trial assessments and visits.
排除标准
- •Note: Ocular exclusion criteria are relevant to both eyes, such that meeting a criterion in either eye excludes the subject from the study
- •Had received Miebo as a prescription or as a study treatment in previous Miebo clinical studies
- •Have any clinically significant ocular surface slit lamp findings at Visit 1 and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters, including:
- •History of eye trauma
- •History of Stevens-Johnson syndrome
- •Active blepharitis or lid margin inflammation
- •DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency)
- •Abnormal lid anatomy causing incomplete eyelid closure
- •Abnormal cornea shape (keratoconus)
- •Corneal epithelial defect or significant confluent or filaments
- •History of herpetic keratitis
- •Ocular or periocular rosacea
- •Use of any of the following ocular therapies within 60 days prior to Visit 1: Vuity®, any topical ocular steroid treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
- •Had a LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 1
- •Had received or removed a permanent punctum plug within 3 months (6 months for dissolvable plugs) prior to Visit 1
- •Use of any eye drops (prescription or over-the counter, such as artificial tears or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hours prior to Visit 1
- •Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
- •Have worn contact lenses within 1 month prior to Visit 1 or planned wear during the study.
- •Have undergone intraocular surgery or ocular laser surgery within 3 months prior to Visit 1; have undergone refractive surgery within 2 years prior to Visit 1
- •Have active ocular or systemic infection (bacterial, viral, or fungal), including fever.
- •Female subjects who are pregnant, nursing, or planning a pregnancy
- •Female subjects of childbearing potential who are not using an acceptable means of birth control; acceptable methods of contraception include hormonal (oral, implantable, injectable, or transdermal) contraception; mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom) contraception; intrauterine device; or surgical sterilization of partner. For non-sexually active female subjects, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
- •Have an uncontrolled systemic disease that, in the opinion of the Investigator, will interfere with the trial
- •Have a known allergy and/or sensitivity to the study treatment
- •Use of any oral medications known to cause ocular drying (eg, antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial
- •Have taken isotretinoin (eg, Accutane, Myorisan, Claravis, Amnesteem) within 6 months prior to Visit 1
- •Have corrected visual acuity (VA) worse than or equal to +0.7 logarithm of the minimum angle of resolution (logMAR), as assessed with Snellen chart at Visit 1
- •Are currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days prior to Visit 1.
研究组 & 干预措施
Miebo treatment
Experimental
干预措施: Miebo (Drug)
结局指标
主要结局
Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3
时间窗: Change from baseline in VAS at Visit 3 (Day 7 ± 1 day)
Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 (Day 7 ± 1 day) Scale name: Visual Analog Scale Range: min: 0%, max: 100%; 0% corresponds to "none" and 100% corresponds to "worst severity possible" Intrepretation: VAS is a subjective measurement tool that consists of a horizontal assessment line, of 100 mm (10 cm) length where patients place a vertical mark to indicate the level of perceived severity of symptoms. Higher values indicate worse disease severity, lower values indicate better outcome with treatment
次要结局
未报告次要终点
研究者
研究点 (7)
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