An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Subjective Comfort Scores
研究概览
简要总结
This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye Questionnaire-8 and examined on four occasions.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •They are of legal age (18 years) and capacity of volunteer.
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •They must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.
- •They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.
- •They are willing to wear their lenses for approximately 14 hours on study days.
- •They have a wearable pair of spectacles, if applicable.
- •They agree not to participate in other clinical research for the duration of this study.
- •They can attain high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses in each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •They have an ocular disorder, which would normally contra-indicate contact lens wear.
- •They have a systemic disorder, which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They have had cataract or corneal refractive surgery.
- •They are pregnant or breast-feeding by self-report.
- •They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report.
- •They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic.
- •They have a history of severe allergic reaction or anaphylaxis.
- •They have a history of cardiac disease or hyperthyroidism.
- •They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
- •They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They have grade 3 or greater of any of the following ocular surface signs which would contraindicate contact lens wear: corneal edema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
结局指标
主要结局
Subjective Comfort Scores
时间窗: 5 and 10 Minutes post-treament
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
时间窗: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
时间窗: Immediately after lens-insertion, 5 and 10 minutes post-treatment
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
次要结局
- Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic(5 and 10 minutes post treatment)
- Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea(Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal)
- Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions(14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment)