NCT05530889撤回不适用
Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Subjective rating of itchiness
研究概览
简要总结
This will be a prospective, randomized, bilateral eye, crossover, non-masked single site pilot study to compare the severity of symptoms of itching between test and control lens after two weeks of wear.
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
- None
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 participants must satisfy all of the following criteria to be enrolled in the study
- •Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Be at least 18 years of age at the time of screening.
- •By self-report, habitually wear soft, daily, spherical contact lenses in both eyes. Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the last 4 weeks.
- •Willing to wear study lenses for at least 5 days per week and 6 hours per day.
- •Possess a wearable pair of spectacles that provide correction for distance vision and agree to wear them on the day of the dispense visit (V2).
- •Must agree and be willing to not wear their habitual contact lenses on the day of the lens dispense visit (V2)
- •Report symptoms of allergy, including itchy eyes.
- •Oral medication and/or eye drops to treat allergy symptoms must have been used for at least 2 weeks, for a minimum of 3 times per week, prior to the screening visit.
- •Must be willing to cease use of habitual eye drops to relieve allergy symptoms during the ACUVUE® Theravision® with Ketotifen wear period.
- •The spherical equivalent of the participant's vertex corrected distance refraction must be between -0.50 and -7.00 DS (inclusive) in each eye.
- •The magnitude of the cylindrical component of the participant's vertex-corrected distance refraction must be no more than -1.00 DC (inclusive) in each eye.
- •Must achieve best corrected visual acuity (BCVA) of at least +0.20 logMAR in each eye.
排除标准
- •Potential participants who meet any of the following criteria will be excluded from participating in the study:
- •Be currently using any ocular medications, with the exception of eye drops for the treatment of their allergy symptoms.
- •Take any medications for which a stable regimen has not been achieved (i.e. have started a new medication or changed dosage of an existing medication within the last four weeks).
- •Have a known hypersensitivity or allergic reaction to ketotifen or sodium fluorescein.
- •Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •Be an employee (e.g., Investigator, Coordinator, Technician) of the Centre for Ocular Research & Education listed on the study Delegation Log or immediate family member of these employees (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse).
- •Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
- •Be currently using bifocal, multifocal or monovision contact lenses, or wear lenses in an extended wear modality (sleep in lenses)
- •Have any active ocular infection of any type.
- •Have clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Have clinically significant (grade 3 or 4) papillary conjunctivitis or bulbar injection which might interfere with contact lens wear and that are unlikely to be related to their ocular allergy (at the investigator's discretion).
- •Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
结局指标
主要结局
Subjective rating of itchiness
时间窗: up to 2-week follow-up
The severity of symptoms of itching will be compared (0-4 itching scale with 0.5 steps) between the test and control lens after 2 weeks of wear.
次要结局
- Subject Preference Questionnaire(at the 2-week follow-up)
- Subjective rating of comfort(up to 2-week follow-up)
- Subjective rating of dryness(up to 2-week follow-up)
- Subjective rating of handling(up to 2-week follow-up)
- Comfortable and total CL wear time(up to 2-week follow-up)
- Subjective rating of vision(up to 2-week follow-up)
- CLDEQ-8 Questionnaire(up to 2-week follow-up)
- MiniRQLQ Questionnaire(up to 2-week follow-up)
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