ISRCTN11525595已完成未知
nderstanding the impact of proactive management to improve symptomatic contact lens wearers success
CooperVision (United States)0 个研究点目标入组 81 人开始时间: 2021年1月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 81
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 18 to 40 years
- •2. Current daily wear soft contact lens wearer who have worn contact lenses for at least six months in total
- •3. CLDEQ-8 =14 and/or comfortable wearing time = 9hrs; with selfreported end of day dryness or discomfort
- •4. Spectacle refraction:
- •Sphere: -6.00D to + 4.00D
- •Astigmatism: 0.00D to -0.75
- •5. Best corrected visual acuity of at least 20/30 in each eye
- •6. No significant ocular signs that would prohibit contact lens wear including:
- •6.1. Blepharitis score <3 (0 to 4-point scale)
- •6.2. Meibomian gland score <3 (0 to 4-point scale)
- •6.3. Corneal staining score <7 (0 to 10-point scale)
- •6.4. Conjunctival staining score <3 on (0 to 4-point scale)
- •6.5. TPH without contact lenses =0.125 mm
- •6.6. OSDI score without contact lenses <13
- •7. Have read and understood the Participant Information Sheet in English
- •8. Have read, signed and dated the Informed Consent
- •9. Have normal eyes with the exception of the need for visual correction
- •10. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
排除标准
- •1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- •2. Monocular participants (only one eye with functional vision) or participants fit with only one lens
- •3. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
- •4. History of herpetic keratitis, ocular surgery or irregular cornea
- •5. Known pregnancy or lactation during the study period as determined by self-report
- •6. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
- •7. Individuals who are unable to read or understand the Participant Information Sheet in English
研究者
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