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OpenTrials
Active, Not Recruiting

NCT Number: NCT07643077

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Latanoprost with preservatives (BAK) once per day for at least 6 months period

Drug

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.

Primary outcomes

  1. Change in ocular microbiome

    Time frame: 6 months

    Alpha and beta diversity before and at least 6 months after the treatment

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 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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