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

NCT07605572 | Recruiting

• 1 other identifier: 193-16/02/2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

2nd Department of Internal Medicine, Research Institute and Diabetes Center, National and Kapodistrian University of Athens, Athens, GRC.

Athens, 12462, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 34310488 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Corneal Diseases

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Vaia Lambadiari, MD, PhD

CONTACT

(0030)2105838000; vlambadiari@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vaia Lambadiari, Professor of Internal Medicine, University of Athens

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 26, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)