Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07605572

Acronym

GALENOS

Enrollment

100

Registered

2026-05-26

Start date

2026-03-01

Completion date

2027-02-28

Last updated

2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cornea, Diabete Mellitus, Diabetes Type 2, Dry Eye Disease (DED), GLP-1, Ocular Surface

Keywords

Dry eye disease, Diabetes Type 2, GLP-1 Receptor Agonists, Cornea

Brief 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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥18 years. 2. Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs). 3. Patients able to provide informed consent for participation in the study.

Exclusion criteria

1. Pregnant or breastfeeding patients. 2. History of multiple severe hypoglycemic episodes within the past two years. 3. Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis. 4. Patients who have undergone cataract surgery or vitrectomy within the past 6 months. 5. History of ketoacidosis or metabolic acidosis. 6. History of corneal transplantation.

Design outcomes

Primary

Measure	Time frame	Description
Changes in Ocular Parameters	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.

Secondary

Measure	Time frame	Description
Change in Tear Film Break-Up Time (BUT)	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 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.
Change in Tear Meniscus Height (TMH)	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): Assessment of changes from baseline in tear meniscus height (TMH), measured in millimeters (mm), as an indicator of tear volume and ocular surface function.

Countries

Greece

Contacts

CONTACTVaia Lambadiari, MD, PhD

vlambadiari@gmail.com(0030)2105838000

Outcome results