Blinking Exercise Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Structured Blinking Exercise Training
BehavioralA 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.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Glaucoma Patients on Topical Therapy + Blink Training (Intervention Arm)Experimental treatment 1 intervention
Group B: Arm 2: Glaucoma Suspects + Blink Training (Control/Comparator Arm)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Symptom Assessment in Dry Eye (SANDE):
Measures frequency and intensity of dry eye symptoms
Time frame
2 and 4 weeks post intervention2
Ocular Surface Disease Index (OSDI):
Assesses severity of dry eye symptoms and their impact on daily activities.
Time frame
two weeks and four weeks after the intervention3
Blink test (ocular comfort after a blink):
Evaluates subjective relief following blinking.
Time frame
2 and 4 weeks post intervention4
Non-invasive tear break-up time (NITBUT):
Objective measure of tear film stability.
Time frame
2 and 4 weeks post interventionSecondary outcomes
1
Blink rate and completeness:
Assessed using high-frame-rate video recordings.
Time frame
2 and 4 weeks post intervention2
Meibomian gland expressibility:
Evaluates gland function through manual expression.
Time frame
2 and 4 weeks post intervention3
Adherence to the blinking exercise:
Tracked via self-report logs or mobile reminders
Time frame
2 weeks post intervention4
Participant acceptability:
Assessed through follow-up interviews.
Time frame
2 weeks post interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: