The Impact of Hypo-osmolar Drops on Contact Lens Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale
研究概览
简要总结
This pilot study will investigate the impact of sterile saline drops that are formulated at hypo-osmolar levels on CL comfort in comparison to an iso-osmolar drop, in a group of symptomatic CL wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 years of age;
- •Has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is willing and able to stay within the School of Optometry and Vision Science building for the duration of each Study Day;
- •Currently wears daily, soft, frequent replacement lenses licensed in Canada (daily, bi-weekly or monthly disposable lenses, no extended wear, no monovision) for at least 3 days/week and 6 hours/day during the 2 months prior to enrolment;
- •Is symptomatic according to the following classification:
- •Reports a difference between average and comfortable wear time with habitual lenses of at least 3 hours;
- •Fall into the symptomatic group as per Young's criteria (Appendix 4).
- •Is able to remove and insert the lenses by themselves;
- •Owns a wearable pair of spectacles;
- •Is willing to wear the study lenses for 10 hours;
- •Has visual acuity (VA) correctable to logMAR 0.20 or better in each eye;
- •Shows an acceptable lens fit with their habitual lenses;
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/ or infection;
- •Has any ocular abnormality that would contraindicate contact lens wear;
- •Has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator may affect the study measures;
- •Is using any systemic or topical medications that in the option of the investigator may affect the study measures;
- •Has any known sensitivity to the diagnostic pharmaceuticals and products to be used in this study;
- •Is pregnant or lactating (by verbal communication) due to potential ocular physiology changes that may affect the study outcome;
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Is a member of the CCLR directly involved in the data collection. *For the purpose of this study, active ocular disease is defined as an infection or inflammation that requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered an active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
结局指标
主要结局
Participant's Subjective Rating of Dryness (Questionnaire) - Likert scale
时间窗: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My eyes feel dry" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Burning (Questionnaire) - Likert scale
时间窗: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My eyes burn" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Stability of Vision (Questionnaire)
时间窗: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated the stability of their vision by subjective questionnaire (un-annotated scale, 0-100, 0=Not stable at all/ very fluctuating, 100=Very stable). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Dryness (Questionnaire)
时间窗: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated the dryness of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Very dry, 100=No dryness at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Foreign Body Sensation (Questionnaire)
时间窗: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated the foreign body sensation of their eyes by subjective questionnaire (un-annotated scale, 0-100, 0=Intense feeling of foreign body sensation, 100=No foreign body sensation at all). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Comfort (Questionnaire)
时间窗: Baseline, 1.5hrs, 3hrs, 4.5hrs, 6hrs, 7.5hrs, 9hrs, End of 1 day
Participants rated their eye comfort by subjective questionnaire (un-annotated scale, 0-100, 0=Very poor comfort, 100=Excellent comfort). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Awareness (Questionnaire) - Likert scale
时间窗: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "I am aware of the lenses in my eyes" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of vision stability (Questionnaire) - Likert scale
时间窗: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My vision is stable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Participant's Subjective Rating of Comfort (Questionnaire) - Likert scale
时间窗: Baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of 1 day.
Participants responded to the statement "My eyes feels comfortable" (5 possible ratings, Strongly agree, agree, undecided, disagree, strongly disagree). Change over time measured at baseline, 1.5 hrs, 3 hrs, 4.5 hrs, 6 hrs, 7.5 hrs, 9 hrs and End of day.
Drop preference (compared with last drop used)
时间窗: End of day 2, End of day 3
Participant's subjective response for drop preference (compared with last drop used) at the end of days 2 and 3. (5 possible ratings: Strongly prefer Day 1, Prefer Day 1, No preference, Prefer Day 2, Strongly prefer day 2 OR Strongly Prefer Day 2, Prefer Day 2, No preference, Prefer Day 3, Strongly prefer day 3)
次要结局
- Tear film osmolarity(Baseline, End of 1 day)
- Lens lag(Baseline, 4.5 hrs, End of 1 Day)
- Conjunctival hyperemia(Baseline, 4.5 hrs, End of 1 Day)
- Tear meniscus height(Baseline, End of 1 day)
- Limbal hyperemia(Baseline, 4.5 hrs, End of 1 Day)
- Lens movement(Baseline, 4.5 hrs, End of 1 Day)
- Lens Tightness(Baseline, 4.5 hrs, End of 1 Day)
- Non-invasive tear film break-up time (NITBUT)(Baseline, End of 1 day)
- Average corneal staining(Baseline, 4.5 hrs, End of 1 Day)
研究者
Centre for Contact Lens Research
Director, Centre for Contact Lens Research
University of Waterloo