NCT07643077

Brief Summary

The effect of latanoprost with preservatives on the ocular surface microbiome

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Mar 2024Aug 2026

Study Start

First participant enrolled

March 20, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 11, 2026

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

June 7, 2026

Last Update Submit

June 7, 2026

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in ocular microbiome

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

    6 months

Study Arms (1)

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

Interventions

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

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.

Newly diagnosed, treatment naive glaucoma patients or those with ocular hypertension

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension

You may qualify if:

  • Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

Location

MeSH Terms

Conditions

Glaucoma

Interventions

LatanoprostPreservatives, Pharmaceutical

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Ophthalmology Department, University Hospital of Ioannina, Greece

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 11, 2026

Study Start

March 20, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 11, 2026

Record last verified: 2025-12

Locations

GR(1)