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NCT Number: NCT07605572

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Athens, 12462, Greece

Location status: Recruiting

Location contact

Vaia Lambadiari

CONTACT

[email protected]

(0030)2105832015

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 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.

  2. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vaia Lambadiari, MD, PhD

CONTACT

[email protected]

(0030)2105838000

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Acronym: GALENOS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 26, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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