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

NCT07643077 — Active not recruiting, 45 participants, University of Ioannina

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RegistryNCT07643077
StatusActive not recruiting
Study typeObservational
Enrollment45 (Estimated)
SponsorUniversity of Ioannina (Other)
ConditionsGlaucoma
InterventionsLatanoprost with preservatives (BAK) once per day for at least 6 months period (Drug)
Datesstart 2024-03-20, primary completion 2026-08-01 (estimated), completion 2026-08-01 (estimated), first posted 2026-06-11, last updated 2026-06-11
Locations1 site in Greece

Related Papers Related Patents Related Grants Related Experts
All trials for Glaucoma All trials of Latanoprost with preservatives (BAK) once per day for at least 6 months period

-Summary

The effect of latanoprost with preservatives on the ocular surface microbiome

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Newly diagnosed, treatment naive glaucoma patients or those with ocular hypertensionDrug: Latanoprost with preservatives (BAK) once per day for at least 6 months period
  • 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.

+Outcome measures

Primary outcomes

  • Change in ocular microbiome [6 months]: Alpha and beta diversity before and at least 6 months after the treatment

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
University Hospital of IoanninaIoannina, EpirusGreece