GlaucomaNCT07643077
CHARACTERIZATION OF THE OCULAR SURFACE MICROBIOME IN THE REGION OF EPIRUS AND MACEDONIA (GREECE)
An observational study of Glaucoma, run by University of Ioannina at 1 site in Greece.
Trial summary
The effect of latanoprost with preservatives on the ocular surface microbiome Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- What is being tested?
- Latanoprost with preservatives (BAK) once per day for at least 6 months period
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 20 Mar 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension
Who may be able to join
- Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The effect of latanoprost with preservatives on the ocular surface microbiome
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Latanoprost with preservatives (BAK) once per day for at least 6 months period
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed, treatment naive glaucoma patients or those with ocular hypertension | Not described Receives: Drug: Latanoprost with preservatives (BAK) once per day for at least 6 months period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular microbiome
Alpha and beta diversity before and at least 6 months after the treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start20 Mar 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Katsanos, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643077
- Sponsor's protocol ID
- 467/30-7-2024
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHARACTERIZATION OF THE OCULAR SURFACE MICROBIOME IN THE REGION OF EPIRUS AND MACEDONIA (GREECE)
- ClinicalTrials.gov ID
- NCT07643077
- Acronym / sponsor ID
- 467/30-7-2024
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of latanoprost with preservatives on the ocular surface microbiome
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension
Key inclusion criteria (1 listed)
- Newly diagnosed treatment naive glaucoma patients or those with ocular hypertension
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost with preservatives (BAK) once per day for at least 6 months periodExisting studies have primarily assessed these differences by comparing treated glaucoma patients to healthy controls, rather than examining changes within the same individuals over time. | Drug | Newly diagnosed, treatment naive glaucoma patients or those with ocular hypertension |
Primary outcome
Change in ocular microbiome
Time frame: 6 months
Alpha and beta diversity before and at least 6 months after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ocular microbiome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.