Dry Eye Disease (DED)NCT07554937
Blinking Exercise Study
A study testing Structured Blinking Exercise Training in people with Dry Eye Disease (DED) and Glaucoma, run by St. Joseph's Healthcare Hamilton.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease (DED), Glaucoma
- What is being tested?
- Structured Blinking Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing Blinking Exercises to Improve Dry Eye Disease in Patients With Glaucoma
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Dry Eye Disease (DED), Glaucoma
- Being tested
- Structured Blinking Exercise Training
- Keywords
- Dry Eye Disease, Ocular Surface Disease, Glaucoma, Blinking Exercise, Behavioral Intervention, Medication Adherence
- Medical subject headings
- Dry Eye Syndromes, Glaucoma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Blinking Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Assessment in Dry Eye (SANDE):
Measures frequency and intensity of dry eye symptoms
Measured: 2 and 4 weeks post intervention
Ocular Surface Disease Index (OSDI):
Assesses severity of dry eye symptoms and their impact on daily activities.
Measured: two weeks and four weeks after the intervention
Blink test (ocular comfort after a blink):
Evaluates subjective relief following blinking.
Measured: 2 and 4 weeks post intervention
Non-invasive tear break-up time (NITBUT):
Objective measure of tear film stability.
Measured: 2 and 4 weeks post intervention
Secondary outcomes (4)
Blink rate and completeness:
Assessed using high-frame-rate video recordings.
Measured: 2 and 4 weeks post intervention
Meibomian gland expressibility:
Evaluates gland function through manual expression.
Measured: 2 and 4 weeks post intervention
Adherence to the blinking exercise:
Tracked via self-report logs or mobile reminders
Measured: 2 weeks post intervention
Participant acceptability:
Assessed through follow-up interviews.
Measured: 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enitan Sogbesan, St. Joseph's Healthcare Hamilton
- Investigators
- Enitan A. Sogbesan, M.D., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554937
- Sponsor's protocol ID
- 19515
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 40467388Tsubota 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.
PubMed 8426634Ruiz-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.
PubMed 37547228Nijm 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.
PubMed 33323704McMonnies 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.
PubMed 31992536Katz 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.
PubMed 21151330Hashemi 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.
PubMed 23927383Guedes G, Tsai JC, Loewen NA. Glaucoma and aging. Curr Aging Sci. 2011 Jul;4(2):110-7. doi: 10.2174/1874609811104020110.
PubMed 21235491Craig 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.
PubMed 28736335Chamard 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.
PubMed 32232968Baudouin 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.
PubMed 20302969Arita 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.
PubMed 39920919
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Blinking Exercises to Improve Dry Eye Disease in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT07554937
- Acronym / sponsor ID
- 19515
- Conditions
- Dry Eye Disease (DED), Glaucoma
- Keywords
- Dry Eye Disease, Ocular Surface Disease, Glaucoma, Blinking Exercise, Behavioral Intervention, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Glaucoma Patients on Topical Therapy + Blink Training (Intervention Arm) | Experimental | Behavioral: Structured Blinking Exercise TrainingParticipants 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Blinking Exercise TrainingA 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. | Behavioural | Arm 1: Glaucoma Patients on Topical Therapy + Blink Training (Intervention Arm) |
Primary outcome
Symptom Assessment in Dry Eye (SANDE):
Time frame: 2 and 4 weeks post intervention
Measures frequency and intensity of dry eye symptoms
Ocular Surface Disease Index (OSDI):
Time frame: two weeks and four weeks after the intervention
Assesses severity of dry eye symptoms and their impact on daily activities.
Blink test (ocular comfort after a blink):
Time frame: 2 and 4 weeks post intervention
Evaluates subjective relief following blinking.
Non-invasive tear break-up time (NITBUT):
Time frame: 2 and 4 weeks post intervention
Objective measure of tear film stability.
4 secondary outcomes
Blink rate and completeness:
Time frame: 2 and 4 weeks post intervention
Meibomian gland expressibility:
Time frame: 2 and 4 weeks post intervention
Adherence to the blinking exercise:
Time frame: 2 weeks post intervention
Participant acceptability:
Time frame: 2 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 40467388Wolffsohn 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.
- Results publication: PubMed 8426634Tsubota 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.
- Results publication: PubMed 37547228Ruiz-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.
- Results publication: PubMed 33323704Nijm 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.
- Results publication: PubMed 31992536McMonnies 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.
- Results publication: PubMed 21151330Katz 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.
- Results publication: PubMed 23927383Hashemi 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.
- Results publication: PubMed 21235491Guedes G, Tsai JC, Loewen NA. Glaucoma and aging. Curr Aging Sci. 2011 Jul;4(2):110-7. doi: 10.2174/1874609811104020110.
- Results publication: PubMed 28736335Craig 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.
- Results publication: PubMed 32232968Chamard 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.
- Results publication: PubMed 20302969Baudouin 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.
- Results publication: PubMed 39920919Arita 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.
- Individual participant dataSharing planned: No. 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
Related trials for Dry Eye Disease (DED)
RecruitingPhase 2
An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Dry Eye Disease (DED)
Recruiting
Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.
DED, Aqueous-deficient Dry Eye Disease
RecruitingObservational study
Association Between Periodontitis and Dry Eye Disease: A Cross-Sectional Study
Periodontitis, Dry Eye Disease (DED)
Active, not recruitingPhase 4
Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery
Dry Eye Disease (DED)
Not yet recruiting
Study of Eye Fatigue From Digital Screens and Its Impact on Visual Performance in People With Normal Vision and Myopia, With and Without Dry Eye Symptoms and Signs
Myopia, Dry Eye Disease (DED)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enitan A. Sogbesan, M.D. principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Structured Blinking Exercise Training in people with Dry Eye Disease (DED) and Glaucoma, run by St. Joseph's Healthcare Hamilton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ladun O. Odediran, MSc. (1-905-573-7777 ext. 38504, odedirao@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Assessment in Dry Eye (SANDE): (time frame: 2 and 4 weeks post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07554937, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.