NCT01819194已完成不适用
Contact Lens Comfort Relative to Meibomian Gland Status
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)
研究概览
简要总结
This trial aims to establish a correlation between patient reported comfort while using soft contact lenses and meibomian gland dysfunction (MGD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must be able to read, understand, and sign the statement of informed consent and receive a fully executed copy of the form.
- •The subject be able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be 18 and less than 39 years of age.
- •The subject must be an adapted soft contact lens wearer in both eyes (Defined as having been a full times lens wearer for at least 3 months).
- •Subjects must be current full time daily wearers of Acuvue Oasys lenses (defined as, at least 6 hours per day, 5 days per week).
- •The subject's spherical equivalent distance refraction must be in the range of 0.00 to -6.00D in each eye.
- •The subject must present at visit 1 with a current copy of their spectacle prescription.
- •The subject must have the best corrected visual acuity of 0.18 or better in each eye as assessed by LogMAR chart.
- •The subject must have normal eyes (i.e., no ocular medication, or infections of any type)
排除标准
- •Wear Acuvue Oasys with Hydraclear Plus on an extended wear basis.
- •Wear Acuvue Oasys with Hydraclear Plus for astigmatism.
- •History of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva; mycobacterial infection of the eye; and/or fungal disease of the eye.
- •Use of concomitant ocular medications during the study period. Topical artificial tears or contact lens lubricants are allowed, but no instillation on the day of examinations.
- •Any systemic disease, autoimmune disease, or use of medications, which may interfere with contact lens wear.
- •Subjects using medications influencing tear production such as steroids, immunosuppressive agents and/or anti-cholinergics (e.g. cold and allergy medications, tricyclic antidepressants) for treatment of autoimmune connective tissue disease may not be enrolled in this study if they have not been on a stable dosing regimen for 30 days prior to the Eligibility Visit. Subjects may use birth control medications since there is inconclusive evidence relative to the influence on tear film.
- •Any infectious disease (e.g. Hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV, by self report).
- •Subjects reporting discomfort at screening visit related to fit or care system abnormalities (both determined by the investigator), ocular conditions such as conjunctival infections, iritis.
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Entropion, ectropion, extrusion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosion,aphakia, or moderate or above corneal distortion by keratometry.
- •Any previous, or planned, ocular or intraocular surgery (radial keratotomy, LASIK, ETC.)
- •Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Monovision or multi-focal contact lens correction
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
- •History of binocular vision abnormality or strabismus
- •History of serious mental illness
- •History of seizures
结局指标
主要结局
Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)
时间窗: Post 3 days of wear
CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale
时间窗: Post 3 days of wear
Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.
次要结局
未报告次要终点
研究者
研究点 (1)
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