NCT06346340已完成4 期
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
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
- 97
- 试验地点
- 24
- 主要终点
- Mean difference between absolute deviations from predicted refractive error in the study eye.
研究概览
简要总结
A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy
详细描述
The primary objective is to determine the effect of preoperative Miebo treatment on the accuracy of preoperative biometry/keratometry and predicted refraction in subjects with dry eye disease (DED) who are already scheduled for cataract surgery.
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):
- •At least 1 eye with a visually significant cataract that has been scheduled for cataract surgery (eligible eye can be a subject's second eye to undergo cataract surgery as long as all eligibility criteria are met in that eye)
- •Candidate for routine, uncomplicated cataract surgery (phacoemulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery)
- •In the Investigator's opinion, subject has potential postoperative pinhole Snellen visual acuity of at least 20/200 in both eyes
- •Tear film break-up time ≤10 sec at Visit 1
- •Total CFS score ≥2 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal), using the National Eye Institute scale at Visit 1
- •Ocular Surface Disease Index (OSDI) ≥23 at Visit 1
- •Able and willing to follow instructions, including participation in all trial assessments and visits.
排除标准
- •Have any clinically significant ocular surface slit-lamp findings in the study eye 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 staining or filaments
- •History of herpetic keratitis
- •Ocular or periocular rosacea
- •Pterygium in either eye
- •Use of any of the following ocular therapies in the study eye within 30 days prior to Visit 1: Vuity®, Qlosi™, 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 in the study eye within 3 months prior to Visit 1
- •Had received or removed a permanent punctum plug in the study eye within 1 month (3 months for dissolvable punctum plugs) prior to Visit 1
- •Use of any eye drops (prescription or over-the-counter, such as artificial tears or Lumify®) and/orTrueTear™ device (intranasal tear neurostimulator) in the study eye 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 in the study eye within 3 months prior to Visit 1; have undergone refractive surgery in the study eye 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 investigational drug
- •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
- •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 difference between absolute deviations from predicted refractive error in the study eye.
时间窗: Assessed at Postop Day 30 ± 7 days
Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
Mean Difference Between Absolute Deviations From Predicted Refractive Error in the Study Eye.
时间窗: Assessed at Postop Day 30 ± 7 days
Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
次要结局
未报告次要终点
研究者
研究点 (24)
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