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Completed

NCT Number: NCT05319470

Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

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.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma; Drugs Ocular Hypertension Ocular Surface Disease

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Hyperemia

Diagnostic Test

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

Schirmer test

Diagnostic Test

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

Visual Fields and OCT RNFL

Diagnostic Test

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

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: 6 months

    Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.

  2. 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.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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