Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Sponsor

Democritus University of Thrace (Other)

Overall Status

Recruiting

CT.gov ID

NCT05319470

Collaborator

(none)

100

Enrollment

Location

10.6

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Glaucoma; Drugs Ocular Surface Disease	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

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Intraocular Pressure (IOP) [6 months]
Intraocular pressure measurement in both eyes using the Goldman applanation tonometer.
Ocular Surface Disease [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 90 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT05319470

Other Study ID Numbers:

ES3/Th11/03-02-2022

First Posted:

Apr 8, 2022

Last Update Posted:

Apr 8, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

glaucoma

travoprost

prostaglandin without preservatives

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Apr 8, 2022