GlaucomaNCT05319470
Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives
An observational study of Glaucoma and Glaucoma; Drugs, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Glaucoma, Glaucoma; Drugs, Ocular Surface Disease
- What is being tested?
- Intraocular pressure (IOP), Tear Break-up Time (TBUT) and Conjuctival Hyperemia
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- 15 Mar 2022to 15 May 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 90 years
- All sexes
- Adult, Older adult
Study population: Adult glaucoma patients already under treatment with travoprost without preservatives.
Who may be able to join
- Patients with glaucoma treated with travoprost without preservatives.
Who cannot join
- Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface.
Read the detailed description
This is a prospective study including patients visiting the outpatient glaucoma clinic of the University General Hospital of Alexandroupolis for their standard evaluation. Study population is already under treatment with a travoprost preparation without preservatives. They will be fully informed about the procedure and the purpose of the study and a written consent will be obtained. For every patient included in the study intraocular pressure will be measured using a Goldman applanation tonometer, according to the standard way of practice at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL measurements will also be obtained. The above measurements will be repeated 6 months after the initial examination.
- Conditions
- Glaucoma, Glaucoma; Drugs, Ocular Surface Disease
- Being tested
- Intraocular pressure (IOP), Tear Break-up Time (TBUT), Conjuctival Hyperemia, Schirmer Test, Visual Fields and OCT RNFL
- Keywords
- glaucoma, travoprost, prostaglandin without preservatives
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure (IOP)Diagnostic test
Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.
Tear Break-up Time (TBUT)Diagnostic test
TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.
Conjuctival HyperemiaDiagnostic test
Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.
Schirmer TestDiagnostic test
Schirmer test will be performed on both eyes to asses tear production.
Visual Fields and OCT RNFLDiagnostic test
Visual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | 100 patients with diagnosed glaucoma receiving travoprost without preservatives Receives: Diagnostic Test: Intraocular pressure (IOP); Diagnostic Test: Tear Break-up Time (TBUT); Diagnostic Test: Conjuctival Hyperemia; Diagnostic Test: Schirmer Test; Diagnostic Test: Visual Fields and OCT RNFL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.
Measured: 6 months
Ocular Surface Disease
Tear breakup time (TBUT), conjuctival hyperemia scoring and Schirmer testing will be used to assess the ocular surface state of the study population.
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 posted8 Apr 2022
- Study start15 Mar 2022
- Primary completion15 Apr 2023
- Study completion15 May 2023
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD,PhD, Study chair, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319470
- Sponsor's protocol ID
- ES3/Th11/03-02-2022
- Status last verified
- Jun 2023
- First submitted
- 1 Apr 2022
- Last updated
- 5 Jul 2023
- 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives
- ClinicalTrials.gov ID
- NCT05319470
- Acronym / sponsor ID
- ES3/Th11/03-02-2022
- Conditions
- Glaucoma, Glaucoma; Drugs, Ocular Surface Disease
- Keywords
- glaucoma, travoprost, prostaglandin without preservatives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 8 Apr 2022 (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.
Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface.
Detailed description
This is a prospective study including patients visiting the outpatient glaucoma clinic of the University General Hospital of Alexandroupolis for their standard evaluation. Study population is already under treatment with a travoprost preparation without preservatives. They will be fully informed about the procedure and the purpose of the study and a written consent will be obtained. For every patient included in the study intraocular pressure will be measured using a Goldman applanation tonometer, according to the standard way of practice at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL measurements will also be obtained. The above measurements will be repeated 6 months after the initial examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Intraocular pressure (IOP), Diagnostic Test: Tear Break-up Time (TBUT), Diagnostic Test: Conjuctival Hyperemia, Diagnostic Test: Schirmer Test, Diagnostic Test: Visual Fields and OCT RNFL100 patients with diagnosed glaucoma receiving travoprost without preservatives |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult glaucoma patients already under treatment with travoprost without preservatives.
Key inclusion criteria (1 listed)
- Patients with glaucoma treated with travoprost without preservatives.
Key exclusion criteria (1 listed)
- Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.
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 |
|---|---|---|
| Intraocular pressure (IOP)Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer. | Diagnostic test | Study Group |
| Tear Break-up Time (TBUT)TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy. | Diagnostic test | Study Group |
| Conjuctival HyperemiaConjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system. | Diagnostic test | Study Group |
| Schirmer TestSchirmer test will be performed on both eyes to asses tear production. | Diagnostic test | Study Group |
| Visual Fields and OCT RNFLVisual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography. | Diagnostic test | Study Group |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 6 months
Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.
Ocular Surface Disease
Time frame: 6 months
Tear breakup time (TBUT), conjuctival hyperemia scoring and Schirmer testing will be used to assess the ocular surface state of the study population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- 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.
Georgios Labiris, MD,PhD study chair
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
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 and Glaucoma; Drugs, run by Democritus University of Thrace 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 1 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: finished, as of the sponsor's last update on 5 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraocular Pressure (IOP) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 5 Jul 2023.