Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg

Официальное название

A Clinical Evaluation of Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mg

Обзор

The objective of this study is to evaluate whether twice-daily use of Tyrvaya improves contact lens comfort in contact lens wearers.

Подробное описание

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.

Вмешательства

• Препарат Tyrvaya
  Tyrvaya (varenicline solution 0.03 mg) is a nasal spray, which is dosed twice daily, that is indicated for treating signs and symptoms of dry eye disease (DED )This dropless ocular surface sparing dosing pattern is ideal for the busy CL patient because they can easily administer Tyrvaya twice a day while keeping their contact lens on.

Первичные конечные точки

• Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) [Срок оценки: Baseline as compared to 12 weeks]

Вторичные конечные точки (3)

• Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) [Срок оценки: 2 and 4 weeks as compared to baseline]
• Visual Analog Scale Scores [Срок оценки: 2 weeks, 4 weeks, and 12 weeks compared to baseline]
• Corneal Fluorescein Staining [Срок оценки: 4 weeks and 12 weeks compared to baseline.]

Критерии участия

Критерии включения

• 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 ≥3.
• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ocular Clinical Trials — Houston

Публикации

• Pucker AD, Tichenor AA. A Review of Contact Lens Dropout. Clin Optom (Auckl). 2020 Jun 25;12:85-94. doi: 10.2147/OPTO.S198637. eCollection 2020. PMID 32612404

Идентификаторы

NCT: NCT07705893 · IRB ID 16875

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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