Ocutec daily disposable contact lens comfort evaluation: a randomised double-masked contralateral study

Ocutec Ltd (UK)0 个研究点目标入组 25 人开始时间: 2015年11月4日最近更新: 2018年7月2日

适应症

试验速览

暂无简介。

•1. Be at least 18 years old and full legal capacity to volunteer
•2. Read, understand and sign written statement of informed consent
•3. Appears able and willing to follow instructions and maintain the appointment schedule
•4. Existing soft contact lens wearer (at least 4 weeks daily wear prior to study)
•5. Require a visual correction in both eyes (monovision allowed but no monofit)
•6. Have a spherical contact lens requirement in the range of -1.00 to -4.00 DS
•7. Have no greater than 1.00 DS difference in contact lens spherical requirements between eyes
•8. Have astigmatism <1.25DC in both eyes
•9. Monocular distance visual acuity correctable to 6/9 (20/40) or better in each eye best sphero-cylindrical refraction
•10. Have normal eyes with no evidence of any ocular abnormality or disease. For the purpose of the study a normal eye is defined as having one of these:
•10.1. Clear central cornea
•10.2. No anterior segment disorder
•10.3. No clinically significant slit lamp findings (corneal oedema, staining, central scarring, infiltrates, active neovascularisation)
•10.4. No other active ocular disease or recent surgery

•1. Any systematic disease affecting ocular health
•2. Any systemic or topical medications that will in the investigators opinion affect ocular physiology or contact lens performance
•3. Have severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of the contact lenses
•4. Has persistent, clinically significant corneal or conjuctival staining using fluorescein dye (> Grade 3)
•5. Is aphakic
•6. Has undergone corneal refractive surgery
•7. Is participating in any other type of eye-related clinical or research study
•8. Pregnancy, lactating or planning a pregnancy at the time of enrolment

发起方

Ocutec Ltd (UK)