ISRCTN13286992进行中（未招募）4 期
Refitting Biofinity® Multifocal contact lenses wearers with MyDay® Multifocal contact lenses
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 40 years and older
- •2. Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® multifocal)
- •3. Spectacle refraction:
- •Distance: Sphere: -6.00D to + 4.00D
- •Astigmatism: 0.00D to -0.75D
- •Near Addition: +0.75D to +2.50D
- •4. Best corrected visual acuity of at least 20/25 in each eye
- •5. The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation.
排除标准
- •1. Acute and subacute inflammation or infection of the anterior chamber of the eye
- •2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear
- •3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
- •4. Severe insufficiency of lacrimal secretion (dry eyes)
- •5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema)
- •6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
- •7. Any active corneal infection (bacterial, fungal, protozoal or viral)
- •8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
- •9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens
- •10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
- •11. History of corneal refractive surgery
- •12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
- •13. Current wearer of the test contact lens MyDay® multifocal contact lens
研究者
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