NCT07054606已完成4 期
A Phase 4, Multicenter, Open-Label Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 6
- 主要终点
- Change from baseline (CFB) in CLDEQ-8 score at Visit 4
研究概览
简要总结
Assess the impact of concomitant Miebo use while wearing contact lenses
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 and sign the Health Insurance Portability and Accountability Act (HIPAA) form as well as the Experimental Subjects Bill of Rights(for subjects in California)
- •Subject must have a documented Manifest Refraction by the PI (or sub-investigator at the same site) performed in the past 180 days prior to screening.
- •Currently wearing soft, frequent-replacement lenses bilaterally (daily-disposable, bi-weekly, or monthly lenses that are available in the US), that have been worn habitually for a minimum of 5 days/week for 6 hours/day over the last 6 months prior to Visit 1 and is willing to wear them for at least 6 hours/day every day during the study (i.e., 30 consecutive days of contact lens wear). Almost all soft contact lenses qualify for study (see exclusion criterion #2 below).
- •Achieves acceptable lens fit as well as ETDRS VA correctable with contact lenses to +0.20 logMAR or better in each eye at Visit 1
- •Able and willing to follow instructions, including participation in all trial assessments and visits
- •Be willing to submit to urine pregnancy test at Visits 1 and 4 for female subjects of childbearing potential.
- •Female subjects of childbearing potential must agree to use 1 medically acceptable method 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. True abstinence may be regarded as an acceptable method of birth control (when this is in line with the preferred and usual lifestyle of the subject); however, if the subject becomes sexually active during the trial, she must use an acceptable method of birth control as defined above for the remainder of the trial. Note: Females of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- •Male subjects with a female partner of childbearing potential, must use at least 1 medically acceptable method of birth control. Note: Acceptable methods of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to receiving Investigational Product. Without a vasectomy, condoms with spermicide must be used throughout the study duration.
排除标准
- •Subjects who do not have a documented Manifest Refraction within 180 days prior to Visit 1 by the Principal Investigator (or sub-investigator at the same site).
- •Subjects who are non-contact lens wearers or who have changed contact lens type/brand within the last 6 months
- •Subjects who wear scleral lenses, rigid gas-permeable lenses, hybrid lenses, custom soft contact lenses with a replacement schedule >30 days, or soft contact lenses on an extended-wear basis (i.e., AirOptix Night and Day contact lenses and other lenses approved for overnight wear)
- •Have any clinically significant ocular surface slit-lamp findings in either eye and/or, in the opinion of the Investigator, have any findings that could interfere with trial parameters or impact a subject's ability to wear contact lenses throughout the study, including:
- •History of Stevens-Johnson syndrome
- •Active blepharitis or lid margin inflammation
- •Dry eye disease 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 ocular malignancy
- •Pterygium or pinguecula in either eye that, in the opinion of the Investigator, could interfere with fit of a soft contact lens
- •Use of any of the following ocular therapies in either eye within 30 days prior to Visit 1: Vuity®, topical ocular steroid treatments, topical antibiotics, topical anti-allergy medications, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication
- •Use of any eye drops (prescription or over-the-counter, such as artificial tears, re-wetting drops, RYZUMVITM, or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) in either eye within 24 hours prior to Visit 1, or plan to use these therapies during the course of the study
- •Have active uncontrolled ocular allergies or ocular allergies that are expected to be active during the trial period
- •Have undergone intraocular surgery or ocular laser surgery in either eye within 3 months prior to Visit 1; have undergone refractive surgery in either eye within 1 year prior to Visit 1
- •Planning to undergo an ocular surgical intervention (e.g., intraocular surgery, ocular surgery, cataract surgery, LASIK, etc.) in either eye during the trial period.
- •Have active ocular or systemic infection (bacterial, viral, or fungal), including fever
- •Be unwilling to submit to a urine pregnancy test at Visits 1 and 4 for women of childbearing potential. Note: Females of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy).
- •Female subjects who are pregnant, nursing, or planning a pregnancy
- •Female subjects of childbearing potential who are not using 1 acceptable method 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. True abstinence may be regarded as an acceptable method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use 1 acceptable method of birth control as defined above for the remainder of the trial
- •Male subjects with a female partner of childbearing potential, who is not willing to use 1 acceptable method of birth control throughout the study. Note: Acceptable methods of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or unwilling to use condoms with spermicide if he has not had a vasectomy at least 3 months prior to receiving Investigational Product.
- •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 Product or diagnostic substances (e.g., fluorescein) to be used in the study
- •Are currently enrolled in any investigational drug or device study or have used Miebo within 30 days prior to Visit 1
研究组 & 干预措施
Miebo (perfluorohexyloctane ophthalmic solution)
Experimental
干预措施: Perfluorohexyloctane ophthalmic solution (Drug)
结局指标
主要结局
Change from baseline (CFB) in CLDEQ-8 score at Visit 4
时间窗: Assessed for approximately 30 days
Unabbreviated scale title: Contact Lens Dry Eye Questionnaire-8 Min: 1 Max: 37 Higher scores mean worse.
次要结局
未报告次要终点
研究者
研究点 (6)
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