NCT07554937

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Dry Eye DiseaseOcular Surface DiseaseGlaucomaBlinking ExerciseBehavioral InterventionMedication Adherence

Outcome Measures

Primary Outcomes (4)

  • Symptom Assessment in Dry Eye (SANDE):

    Measures frequency and intensity of dry eye symptoms

    2 and 4 weeks post intervention

  • Ocular Surface Disease Index (OSDI):

    Assesses severity of dry eye symptoms and their impact on daily activities.

    two weeks and four weeks after the intervention

  • Blink test (ocular comfort after a blink):

    Evaluates subjective relief following blinking.

    2 and 4 weeks post intervention

  • Non-invasive tear break-up time (NITBUT):

    Objective measure of tear film stability.

    2 and 4 weeks post intervention

Secondary Outcomes (4)

  • Blink rate and completeness:

    2 and 4 weeks post intervention

  • Meibomian gland expressibility:

    2 and 4 weeks post intervention

  • Adherence to the blinking exercise:

    2 weeks post intervention

  • Participant acceptability:

    2 weeks post intervention

Study Arms (2)

Arm 1: Glaucoma Patients on Topical Therapy + Blink Training (Intervention Arm)

EXPERIMENTAL

Participants in this arm are patients with a confirmed diagnosis of glaucoma who are currently using at least one topical intraocular pressure-lowering medication. In addition to continuing their prescribed glaucoma therapy without modification, participants will undergo a structured blink training program. Interventions: Intervention Name: Structured Blink Training Exercise Type: Behavioral Intervention Description: Participants will perform a standardized blinking exercise consisting of 15 cycles of a close-squeeze-open eyelid sequence, completed three times daily (morning, afternoon, evening) for a duration of 2 weeks. Instruction will be provided in-person with written guidance, and participants will be encouraged to use a mirror or smartphone for technique feedback. Adherence will be monitored using daily logs and optional reminder prompts.

Behavioral: Structured Blinking Exercise Training

Arm 2: Glaucoma Suspects + Blink Training (Control/Comparator Arm)

NO INTERVENTION

Participants in this arm are glaucoma suspects who are not yet receiving topical intraocular pressure-lowering therapy. Participants will not receive pharmacologic glaucoma treatment during the study but will perform the same structured blink training protocol as the intervention group. Interventions: Intervention Name: Structured Blink Training Exercise Type: Behavioral Intervention Description: Identical blink training protocol as Arm 1 (15 cycles of close-squeeze-open blinking, three times daily for 2 weeks). Instruction, adherence monitoring, and reminders will be the same as in the intervention arm. Background Treatment (Standard Monitoring): Routine clinical observation for glaucoma suspects, including intraocular pressure monitoring as per standard care, without initiation of topical therapy during the study period. Intervention Summary Across Arms This study evaluates the effect of a structured blink training regimen on dry eye disease outcomes in two clinically distinct po

Interventions

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.

Arm 1: Glaucoma Patients on Topical Therapy + Blink Training (Intervention Arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Guedes G, Tsai JC, Loewen NA. Glaucoma and aging. Curr Aging Sci. 2011 Jul;4(2):110-7. doi: 10.2174/1874609811104020110.

  • Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.

  • Chamard C, Larrieu S, Baudouin C, Bron A, Villain M, Daien V. Preservative-free versus preserved glaucoma eye drops and occurrence of glaucoma surgery. A retrospective study based on the French national health insurance information system, 2008-2016. Acta Ophthalmol. 2020 Nov;98(7):e876-e881. doi: 10.1111/aos.14410. Epub 2020 Mar 31.

  • Baudouin C, Labbe A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010 Jul;29(4):312-34. doi: 10.1016/j.preteyeres.2010.03.001. Epub 2010 Mar 17.

  • Arita R, Fukuoka S, Matsumoto R, Kaido M. Effects of blinking exercises on palpebral fissure height and tear film parameters. Ocul Surf. 2025 Apr;36:237-243. doi: 10.1016/j.jtos.2025.02.003. Epub 2025 Feb 5.

MeSH Terms

Conditions

Dry Eye SyndromesGlaucomaMedication Adherence

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesOcular HypertensionPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Enitan A. Sogbesan, M.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ladun O. Odediran, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment model with two groups defined by clinical status. The intervention group includes adults with glaucoma using topical medications, while the control group includes glaucoma suspects not receiving treatment. The study is non-randomized, with assignment based on diagnosis. All participants will perform a standardized blinking exercise, and outcomes will be compared between groups to evaluate its effect on dry eye disease symptoms and ocular surface measures. Assessments will be conducted at baseline, 2 weeks (post-intervention), and 4 weeks (follow-up) to evaluate short-term effects and durability.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

IPD from this study will not be made publicly available due to the small sample size and single-center design, which may increase the risk of participant re-identification despite de-identification procedures. Additionally, data are collected under institutional ethics approval with restrictions on data sharing beyond the study team. However, aggregated results and summary findings will be disseminated through peer-reviewed publications and presentations to support transparency and scientific contribution