Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

June 30, 2023 updated by: Georgios Labiris, Democritus University of Thrace
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Department of Ophthalmology, University Hospital of Alexandroupolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Adult glaucoma patients already under treatment with travoprost without preservatives.

Description

Inclusion Criteria:

  • Patients with glaucoma treated with travoprost without preservatives.

Exclusion Criteria:

  • Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Group
100 patients with diagnosed glaucoma receiving travoprost without preservatives
Diagnostic test: Intraocular pressure (IOP)
Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.
Diagnostic test: Tear Break-up Time (TBUT)
TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.
Diagnostic test: Conjuctival Hyperemia
Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.
Diagnostic test: Schirmer Test
Schirmer test will be performed on both eyes to asses tear production.
Diagnostic test: Visual Fields and OCT RNFL
Visual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure (IOP)
Time Frame: 6 months
Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Investigators

  • Study Chair: Georgios Labiris, MD,PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

April 15, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES3/Th11/03-02-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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