A Clinical Evaluation of Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
研究概览
简要总结
The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
详细描述
Although more than 140 million people worldwide wear contact lenses, approximately 20% discontinue use, with discomfort being the primary reason. Contact lens discomfort is a multifactorial condition influenced by environmental factors, patient compliance, lens design, and fit, and is often associated with underlying dry eye disease. Dry eye can significantly reduce comfort and contribute to contact lens dropout.
Tyrvaya® (varenicline solution 0.03 mg) is a twice-daily nasal spray approved to relieve the signs and symptoms of dry eye disease. The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult male and female subjects of any race or ethnicity who are ≥18 years of age.
- •Best corrected CL visual acuity of 0.3 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/40).
- •Soft 1-day silicone hydrogel CL wearer (daily disposable only)
- •Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores (CLDEQ-8 scores ≥ 12).16
- •A VAS score of ≥40 for Eye Dryness and End of Day Contact Lens Discomfort;18, 19
- •A corneal fluorescein staining on the original NEI scale of ≥
- •Habitually wears soft CLs for a minimum of 5 days per week for 6 hours per day during the month prior to enrollment.20
- •Willing to maintain habitual CL wear routine for the 3 months duration of the study.20
- •Willing to only use Tyrvaya nasal spray prescription dry eye treatment for the 3 months duration of the study.
- •Willing to not use any lipid containing artificial tear (AT) for the 3 months duration of the study.
- •Willing to only use non-lipid containing preservative free artificial tear for the 3 months duration of the study if needed, but no more than 4 times per day; also must agree to record frequency of daily AT use if applicable.
- •Willing to record daily time for CL application, removal, and Tyrvaya applications.
- •Habitual CLs have an acceptable fit (good centration, movement, and coverage
排除标准
- •Any history of Tyrvaya use within six months of enrollment
- •Are currently an overnight CL wearer.
- •Are currently wearing rigid gas permeable CLs, scleral CL, hybrid CLs, or reusable soft CLs.
- •Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- •Have a history of ocular surgery within the past 12 months.
- •Have a history of viral eye disease.
- •Have a history of severe ocular trauma, active ocular infection or inflammation.
- •Have ever used using isotretinoin-derivates (e.g., Accutane).
- •Are currently taking ocular medications or plan to during the study (e.g., DED, glaucoma, etc).
- •Subjects with meibomian gland blockage or significant atrophy (e.g., severe MGD). Currently having >50% blockage of Meibomian glands in more than two eyelids
- •Having blepharitis and/or demodex blepharitis > grade 1
- •Have had a physical meibomian gland dysfunction treatment withing three months of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.).
- •Have used a prescription DED or ocular surface disease medication in the last 1 month.
- •Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation.
- •Are pregnant or breast feeding or plan to get pregnant.
- •Are a student, employee, or relative of the study team.
研究组 & 干预措施
Tyrvaya
Participants will be given Tryvaya (Varenicline Solution Nasal Spray 0.03 mg) and instructed to use it twice daily while wearing their contact lenses to determine if the spray relieves symptoms associated with dry eye disease, and thus increases contact lens comfort.
干预措施: Tyrvaya (Drug)
结局指标
主要结局
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
时间窗: Baseline as compared to 12 weeks
The contact lens dry eye questionnaire will be utilized to determine contact lens comfort with lower scores indicating more comfort.
次要结局
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)(2 and 4 weeks as compared to baseline)
- Visual Analog Scale Scores(2 weeks, 4 weeks, and 12 weeks compared to baseline)
- Corneal Fluorescein Staining(4 weeks and 12 weeks compared to baseline.)