Blinking Exercise Study

Официальное название

Optimizing Blinking Exercises to Improve Dry Eye Disease in Patients With Glaucoma

Обзор

The goal of this clinical trial is to evaluate whether a structured blinking exercise can improve symptoms and signs of dry eye disease (DED) in adults with glaucoma who are using topical intraocular pressure-lowering medications. The study will also assess the effects of the intervention on tear film stability, blink function, and participant adherence to the exercise. The main questions this study aims to answer are: Does a two-week structured blinking exercise reduce dry eye symptoms, as measured by the Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE) questionnaires? Does the blinking exercise improve objective measures of ocular surface health, including non-invasive tear break-up time (NITBUT) and blink dynamics? Researchers will compare glaucoma patients receiving topical medications (intervention group) with glaucoma suspects not using topical therapy (control group) to evaluate the effectiveness of the blinking exercise on dry eye outcomes. Participants in both groups will receive instruction on a standardized blinking exercise protocol consisting of repeated close-squeeze-open blinking cycles performed three times daily for two weeks. Participants will attend study visits at baseline, 2 weeks (post-intervention), and 4 weeks (follow-up). At each visit, participants will complete validated dry eye questionnaires and undergo non-invasive assessments of tear film stability, blink characteristics, and meibomian gland function. Adherence to the blinking exercise will be monitored using self-reported logs or reminders.

Подробное описание

Dry eye disease (DED) is a chronic, multifactorial disorder of the ocular surface characterized by tear film instability, inflammation, and ocular discomfort. The prevalence of DED is significantly higher in patients with glaucoma, largely due to long-term use of topical intraocular pressure-lowering medications. Many of these medications contain preservatives, such as benzalkonium chloride, which are associated with ocular surface toxicity, tear film disruption, and inflammation. As a result, glaucoma patients frequently experience worsening dry eye symptoms, reduced quality of life, and decreased adherence to prescribed therapy, potentially compromising disease control and increasing the risk of vision loss.

In addition to pharmacologic factors, behavioral contributors such as reduced or incomplete blinking play an important role in the development and progression of DED. Inadequate blinking impairs tear film distribution, reduces lipid layer replenishment, and increases tear evaporation. These effects are particularly pronounced during prolonged visual tasks such as screen use. Despite the known importance of blink dynamics in ocular surface health, current management strategies for DED in glaucoma patients primarily focus on pharmacological or surgical approaches, with limited attention to modifiable behavioral interventions.

Blinking exercises have emerged as a promising non-pharmacological strategy to improve tear film stability and ocular surface function. Prior studies in non-glaucoma populations have demonstrated that structured blinking exercises can improve tear film parameters, meibomian gland function, and subjective comfort. However, there is limited evidence evaluating the effectiveness of such interventions in glaucoma patients, who represent a high-risk population due to chronic medication exposure.

This study is a prospective, controlled interventional trial designed to evaluate the effect of a structured blinking exercise on both subjective symptoms and objective signs of DED in adults with glaucoma. The intervention group will include patients with a confirmed diagnosis of glaucoma who are currently using at least one topical intraocular pressure-lowering medication. The control group will consist of glaucoma suspects who are not receiving topical therapy. Allocation to groups is based on clinical status and is not randomized.

Participants in both groups will be instructed in a standardized blinking exercise protocol consisting of 15 cycles of close-squeeze-open blinking, performed three times daily for a period of two weeks. Instruction will be provided through in-person demonstration and written materials, and participants will be encouraged to use reminders or tracking tools to support adherence.

Participants will attend three study visits: baseline, 2 weeks (post-intervention), and 4 weeks (follow-up). At each visit, validated subjective and objective assessments of dry eye will be performed. Primary outcome measures include the Ocular Surface Disease Index (OSDI), the Symptom Assessment in Dry Eye (SANDE), a blink-related comfort test, and non-invasive tear break-up time (NITBUT). Secondary outcomes include blink rate and completeness assessed through video analysis, meibomian gland function, adherence to the blinking exercise, and participant-reported acceptability.

The study aims to determine whether a brief, low-cost behavioral intervention can improve ocular surface health and reduce symptoms of DED in glaucoma patients. By targeting a modifiable behavioral factor, this intervention has the potential to complement existing glaucoma management strategies, improve patient comfort, and support adherence to long-term therapy. Findings from this pilot study will provide preliminary evidence to inform the design of larger randomized controlled trials and may contribute to the integration of behavioral interventions into comprehensive glaucoma care.

Вмешательства

• Поведенческое Structured Blinking Exercise Training
  A standardized, non-drug blink exercise program where participants perform 15 close-squeeze-open blink cycles, three times daily for two weeks. It is designed specifically for glaucoma patients with dry eye, focuses on improving blink mechanics and tear film stability, includes guided instruction and adherence support, and is used alongside existing glaucoma treatment without modifying medications.

Первичные конечные точки

• Symptom Assessment in Dry Eye (SANDE): [Срок оценки: 2 and 4 weeks post intervention]
• Ocular Surface Disease Index (OSDI): [Срок оценки: two weeks and four weeks after the intervention]
• Blink test (ocular comfort after a blink): [Срок оценки: 2 and 4 weeks post intervention]
• Non-invasive tear break-up time (NITBUT): [Срок оценки: 2 and 4 weeks post intervention]

Вторичные конечные точки (4)

• Blink rate and completeness: [Срок оценки: 2 and 4 weeks post intervention]
• Meibomian gland expressibility: [Срок оценки: 2 and 4 weeks post intervention]
• Adherence to the blinking exercise: [Срок оценки: 2 weeks post intervention]
• Participant acceptability: [Срок оценки: 2 weeks post intervention]

Критерии участия

Критерии включения

• 18 years of age or older.
• Those in the intervention group must have a confirmed diagnosis of glaucoma and be using at least one topical antiglaucoma medication.
• Control participants must be glaucoma suspects who have not yet commenced topical therapy.

Критерии исключения

• Glaucoma patients who have had ocular surgery within the previous six months, contact lens wear, systemic inflammatory or autoimmune diseases affecting the ocular surface, or other ocular surface disorders such as severe blepharitis or keratoconjunctivitis sicca.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Wolffsohn JS, Trave-Huarte S, Bahra I, Finch C, Anyaegbu U, Garcia-Porta N, Kingsnorth A. Optimisation of blinking exercises for dry eye disease. Cont Lens Anterior Eye. 2025 Oct;48(5):102453. doi: 10.1016/j.clae.2025.102453. Epub 2025 Jun 3. PMID 40467388
• Tsubota K, Nakamori K. Dry eyes and video display terminals. N Engl J Med. 1993 Feb 25;328(8):584. doi: 10.1056/NEJM199302253280817. No abstract available. PMID 8426634
• Ruiz-Lozano RE, Azar NS, Mousa HM, Quiroga-Garza ME, Komai S, Wheelock-Gutierrez L, Cartes C, Perez VL. Ocular surface disease: a known yet overlooked side effect of topical glaucoma therapy. Front Toxicol. 2023 Jul 21;5:1067942. doi: 10.3389/ftox.2023.1067942. eCollection 2023. PMID 37547228
• Nijm LM, De Benito-Llopis L, Rossi GC, Vajaranant TS, Coroneo MT. Understanding the Dual Dilemma of Dry Eye and Glaucoma: An International Review. Asia Pac J Ophthalmol (Phila). 2020 Dec;9(6):481-490. doi: 10.1097/APO.0000000000000327. PMID 33323704
• McMonnies CW. The clinical and experimental significance of blinking behavior. J Optom. 2020 Apr-Jun;13(2):74-80. doi: 10.1016/j.optom.2019.09.002. Epub 2020 Jan 25. PMID 31992536
• Katz G, Springs CL, Craven ER, Montecchi-Palmer M. Ocular surface disease in patients with glaucoma or ocular hypertension treated with either BAK-preserved latanoprost or BAK-free travoprost. Clin Ophthalmol. 2010 Nov 3;4:1253-61. doi: 10.2147/OPTH.S14113. PMID 21151330
• Hashemi H, Khabazkhoob M, Kheirkhah A, Emamian MH, Mehravaran S, Shariati M, Fotouhi A. Prevalence of dry eye syndrome in an adult population. Clin Exp Ophthalmol. 2014 Apr;42(3):242-8. doi: 10.1111/ceo.12183. Epub 2013 Sep 13. PMID 23927383
• Guedes G, Tsai JC, Loewen NA. Glaucoma and aging. Curr Aging Sci. 2011 Jul;4(2):110-7. doi: 10.2174/1874609811104020110. PMID 21235491

Идентификаторы

NCT: NCT07554937 · 19515

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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