ACTRN12624000317594招募中Unknown
Changes to tear pro-inflammatory proteins (cytokines) in new contact lens wearers.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Male or female, aged 18-45 years of age;
- •2.Provide written informed consent and documentation, in accordance with privacy requirements, obtained prior to performing any study procedures;
- •3.Ability to understand and follow study instruction, with the intention of completing all of the required study visits;
- •4.In good general health;
- •5.Have never worn CLs;
- •6.Have a CL spherical prescription range of -0.50 to -6.00 D and +0.50 to +4.00 D and a CL cylindrical prescription range of up to -2.25 DC.
- •7.An acceptable soft CL fit and vision in both eyes with Clariti 1 Day contact lenses (sphere or toric), per the judgement of the study investigator;
- •8.Demonstrated capacity for independent, competent and safe CL application and removal at Visit 2, per the judgement of the study investigator;
- •9.Be motivated and willing to wear CLs for a minimum of four days per week, eight hours per day, over the study duration;
- •10.Best-corrected visual acuity with CL correction of at least 6/9 (20/30) in each eye;
- •11.Not regularly (once per day only) using artificial tear eye drops in the month prior to enrolment, or planned over the course of the study.
排除标准
- •1.Have any known active ocular disease and/or infection (including DED);
- •2.Presence of any of the following conditions: active ocular inflammation, active ocular allergy, a corneal disorder or abnormality that could affect corneal sensitivity or normal spreading of the tear film (except superficial punctate keratitis), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment investigator may interfere with the interpretation of the study results;
- •3.Have any ocular injury to either eye in the 12 weeks prior to Visit 1;
- •4.Have undergone any ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned over the course of their participation in the study;
- •5.Any prior history of laser refractive eye surgery;
- •6.Have a known allergy to, or previous reaction to, any eye drops required for the study;
- •7.Presence of significant corneal scarring or a physical factor that impairs the ability to perform corneal imaging;
- •8.Clinically significant dry eye disease, as specified in the TFOS DEWS II definition, defined by dry eye symptoms (i.e., an Ocular Surface Disease Index (OSDI) score greater than or equal to 13, out of 100 (Schiffman et al., 2000)) and one or more of the following clinical signs (Wolffsohn et al., 2017):
- •a.Tear osmolarity of greater than or equal to 308 mOsm/L in either eye or interocular differences greater than 8mOsm/L;
- •b.TBUT less than 10 sec in either eye;
- •c.Ocular surface staining: greater than 5 corneal spots, greater than 9 conjunctival spots, or lid margin (greater than or equal to 2 mm length and greater than or equal to 25% width)
- •9.Current use of any topical medications other than artificial lubricant eye drops;
- •10.Women who are pregnant or breastfeeding at the time of study entry or who plan to become pregnant during the study (as reported by the participant);
- •11.Any vaccination within 1 week of Visit 1, by self-report;
- •12. Any upper respiratory viral infection within 2 weeks of Visit 1, by self-report;
- •13.Inability to sit/lie supine comfortably during the examination procedures;
- •14.Participation in an interventional clinical trial within the previous 30 days, or currently enrolled in an interventional clinical trial;
- •15.Current use of any eye drop or other therapy, or history of an intervention, that may make CL wear risky or challenging (e.g., use of glaucoma eye drop medications, filtering bleb, etc.);
- •16.A condition or situation that, in the opinion of the study investigator, will limit the potential participant’s ability to comply with the study protocol or might adversely affect their safety.
研究者
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