Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

NCT ID: NCT05319470

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2023-05-15

Brief Summary

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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

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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

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Glaucoma Glaucoma; Drugs Ocular Surface Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

100 patients with diagnosed glaucoma receiving travoprost without preservatives

Intraocular pressure (IOP)

Intervention Type DIAGNOSTIC_TEST

Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.

Tear Break-up Time (TBUT)

Intervention Type DIAGNOSTIC_TEST

TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.

Conjuctival Hyperemia

Intervention Type DIAGNOSTIC_TEST

Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.

Schirmer Test

Intervention Type DIAGNOSTIC_TEST

Schirmer test will be performed on both eyes to asses tear production.

Visual Fields and OCT RNFL

Intervention Type DIAGNOSTIC_TEST

Visual field examination using a Humphrey perimeter and measurement of peripapillary retinal nerve fiber layer thickness with optical coherence tomography.

Interventions

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Intraocular pressure (IOP)

Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.

Intervention Type DIAGNOSTIC_TEST

Tear Break-up Time (TBUT)

TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.

Intervention Type DIAGNOSTIC_TEST

Conjuctival Hyperemia

Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.

Intervention Type DIAGNOSTIC_TEST

Schirmer Test

Schirmer test will be performed on both eyes to asses tear production.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD,PhD

Role: STUDY_CHAIR

Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Locations

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Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

Other Identifiers

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ES3/Th11/03-02-2022

Identifier Type: -

Identifier Source: org_study_id

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