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
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