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临床试验/ISRCTN11525595
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

发起方
CooperVision (United States)

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