CHARACTERIZATION OF THE OCULAR SURFACE MICROBIOME IN THE REGION OF EPIRUS AND MACEDONIA (GREECE)

The effect of latanoprost with preservatives on the ocular surface microbiome

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Latanoprost with preservatives (BAK) once per day for at least 6 months period

Detailed Description

Evidence suggests that the ocular surface microbiome of patients using preserved glaucoma eye drops differs from that of healthy individuals. These microbial changes have been linked to both the glaucoma treatment itself and the presence of preservatives, particularly benzalkonium chloride (BAK), in the eye drops. However, existing studies have primarily assessed these differences by comparing treated glaucoma patients to healthy controls, rather than examining changes within the same individuals over time.

The aim of this study is to evaluate how glaucoma medications containing the preservative benzalkonium chloride affect the ocular surface microbiome in the same patients before and after the initiation of therapy.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

Study Locations

• Greece
  • Epirus
    • Ioannina, Epirus, Greece, 45500
      • University Hospital of Ioannina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension

Description

Inclusion Criteria:

Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension

Exclusion Criteria:

• Patients' history of recent ocular surgery or trauma,
• Patient with any type of conjunctivitis and ocular surface inflammation recent to the time of diagnosis
• Patients using topical antibiotics
• Contact lenses wearers
• Patients in other chronic treatments with eye drops

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newly diagnosed, treatment naive glaucoma patients or those with ocular hypertension	Drug: Latanoprost with preservatives (BAK) once per day for at least 6 months period; Existing studies have primarily assessed these differences by comparing treated glaucoma patients to healthy controls, rather than examining changes within the same individuals over time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ocular microbiome	Alpha and beta diversity before and at least 6 months after the treatment	6 months

Collaborators and Investigators

• Sponsor: University of Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Pharmaceutical Preparations; Fatty Acids; Lipids; Chemical Actions and Uses; Biological Factors; Specialty Uses of Chemicals; Pharmaceutic Aids; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Latanoprost; Preservatives, Pharmaceutical
• Other Study ID Numbers: 467/30-7-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No