Dry Eye Disease (DED)GALENOSNCT07605572
Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity
An observational study of Dry Eye Disease (DED) and Diabete Mellitus, run by Attikon Hospital at 1 site in Greece.
Trial summary
Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED), Diabete Mellitus, GLP-1
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2026to 28 Feb 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The diagnosis of diabetes mellitus will be established according to the diagnostic criteria defined by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and the European Association for the Study of Obesity (EASO). Male and/or female patients attending the regular outpatient ophthalmology clinics, with stable refraction over the past two years, without pathological corneal findings (including corneal ulcer, keratoconus, corneal dystrophies, corneal trauma/abrasions), no history of corneal infections during the last 2 years, and no history of refractive surgery will be included. To ensure the objectivity of the results, the assessment of dry eye disease parameters will be performed by an ophthalmologist blinded to the patient's study group allocation (single-blinded design), thereby minimizing the possibility of observer bias during data collection.
Who may be able to join
- Age ≥18 years.
- Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).
- Patients able to provide informed consent for participation in the study.
Who cannot join
- Pregnant or breastfeeding patients.
- History of multiple severe hypoglycemic episodes within the past two years.
- Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
- Patients who have undergone cataract surgery or vitrectomy within the past 6 months.
- History of ketoacidosis or metabolic acidosis.
- History of corneal transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
2nd Department of Internal Medicine, Research Institute and Diabetes Center, National and Kapodistrian University of Athens, Athens, GRC.
Athens, 12462
Vaia Lambadiari, (0030)2105832015, vlambadiari@gmail.com
About this study
Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.
Read the detailed description
This prospective cohort study aims to shed a light to the effects of GLP-1 RAs on Dry Eye Disease in Patients with Type 2 Diabetes Mellitus and Obesity.
- Conditions
- Dry Eye Disease (DED), Diabete Mellitus, GLP-1, Ocular Surface, Diabetes Type 2, Cornea
- Keywords
- Dry eye disease, Diabetes Type 2, GLP-1 Receptor Agonists, Cornea
- Medical subject headings
- Dry Eye Syndromes, Diabetes Mellitus, Diabetes Mellitus, Type 2, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 50 patients who will receive GLP-1 RAs (Semaglutide) therapy for overweight/obesity, with or without type 2 diabetes mellitus. | |
| Group B | 50 individuals who will be included in the control group and will not receive GLP-1 RA therapy, matched for age, sex, and BMI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ocular Parameters
Change in Best-Corrected Visual Acuity (BCVA): Assessment of changes in best-corrected visual acuity (BCVA) using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
Measured: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
Secondary outcomes (2)
Change in Tear Film Break-Up Time (BUT)
Change in Tear Film Break-Up Time (BUT): Assessment of changes from baseline in tear film break-up time (BUT), measured in seconds (s), as an indicator of tear film stability and ocular surface function.
Measured: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
Change in Tear Meniscus Height (TMH)
Change in Tear Meniscus Height (TMH): Assessment of changes from baseline in tear meniscus height (TMH), measured in millimeters (mm), as an indicator of tear volume and ocular surface function.
Measured: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VAIA LAMBADIARI, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605572
- Sponsor's protocol ID
- 193-16/02/2026
- Acronym
- GALENOS
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yamanishi R, Sawada N, Hanyuda A, Uchino M, Kawashima M, Yuki K, Tsubota K, Kato T, Saito I, Arima K, Mizukami S, Tanno K, Sakata K, Yamagishi K, Iso H, Yasuda N, Shimazu T, Yamaji T, Goto A, Inoue M, Iwasaki M, Tsugane S; JPHC-NEXT Group. Relation Between Body Mass Index and Dry Eye Disease: The Japan Public Health Center-Based Prospective Study for the Next Generation. Eye Contact Lens. 2021 Aug 1;47(8):449-455. doi: 10.1097/ICL.0000000000000814.
PubMed 34310488
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity
- ClinicalTrials.gov ID
- NCT07605572
- Acronym / sponsor ID
- GALENOS / 193-16/02/2026
- Conditions
- Dry Eye Disease (DED), Diabete Mellitus, GLP-1, Ocular Surface, Diabetes Type 2, Cornea
- Keywords
- Dry eye disease, Diabetes Type 2, GLP-1 Receptor Agonists, Cornea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 May 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.
Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.
Detailed description
This prospective cohort study aims to shed a light to the effects of GLP-1 RAs on Dry Eye Disease in Patients with Type 2 Diabetes Mellitus and Obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –50 patients who will receive GLP-1 RAs (Semaglutide) therapy for overweight/obesity, with or without type 2 diabetes mellitus. |
| Group B | – | –50 individuals who will be included in the control group and will not receive GLP-1 RA therapy, matched for age, sex, and BMI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The diagnosis of diabetes mellitus will be established according to the diagnostic criteria defined by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and the European Association for the Study of Obesity (EASO). Male and/or female patients attending the regular outpatient ophthalmology clinics, with stable refraction over the past two years, without pathological corneal findings (including corneal ulcer, keratoconus, corneal dystrophies, corneal trauma/abrasions), no history of corneal infections during the last 2 years, and no history of refractive surgery will be included. To ensure the objectivity of the results, the assessment of dry eye disease parameters will be performed by an ophthalmologist blinded to the patient's study group allocation (single-blinded design), thereby minimizing the possibility of observer bias during data collection.
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).
- Patients able to provide informed consent for participation in the study.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding patients.
- History of multiple severe hypoglycemic episodes within the past two years.
- Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
- Patients who have undergone cataract surgery or vitrectomy within the past 6 months.
- History of ketoacidosis or metabolic acidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Ocular Parameters
Time frame: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
Change in Best-Corrected Visual Acuity (BCVA): Assessment of changes in best-corrected visual acuity (BCVA) using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
2 secondary outcomes
Change in Tear Film Break-Up Time (BUT)
Time frame: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
Change in Tear Meniscus Height (TMH)
Time frame: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.
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 2 Jun 2026.
- Background: PubMed 34310488Yamanishi R, Sawada N, Hanyuda A, Uchino M, Kawashima M, Yuki K, Tsubota K, Kato T, Saito I, Arima K, Mizukami S, Tanno K, Sakata K, Yamagishi K, Iso H, Yasuda N, Shimazu T, Yamaji T, Goto A, Inoue M, Iwasaki M, Tsugane S; JPHC-NEXT Group. Relation Between Body Mass Index and Dry Eye Disease: The Japan Public Health Center-Based Prospective Study for the Next Generation. Eye Contact Lens. 2021 Aug 1;47(8):449-455. doi: 10.1097/ICL.0000000000000814.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease (DED) and Diabete Mellitus, run by Attikon Hospital at 1 site in Greece.
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 6 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Vaia Lambadiari, MD, PhD ((0030)2105838000, vlambadiari@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Ocular Parameters (time frame: All ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.). 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 NCT07605572, which also lists 1 linked publication.
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 2 Jun 2026.