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NCT05319470 Clinical Trial

Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Glaucoma Clinical Trial

Official title:
Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05319470
Other study ID # ES3/Th11/03-02-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date May 15, 2023

Study information
Verified date June 2023
Source Democritus University of Thrace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date May 15, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers
Gender All
Age group 35 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Intraocular pressure (IOP)
Measurement of intraocular pressure in both eyes of the study population using the Goldman applanation tonometer.
• Tear Break-up Time (TBUT)
TBUT will be calculated after instillation of a drop of fluorescein dye, by slit lamp biomicroscopy.
• Conjuctival Hyperemia
Conjunctival hyperemia will be assessed by slit lamp biomicroscopy using a validated grading system.
• Schirmer Test
Schirmer test will be performed on both eyes to asses tear production.
• 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.

Locations
Country Name City State
Greece Department of Ophthalmology, University Hospital of Alexandroupolis Alexandroupolis Evros

Sponsors (1)
Lead Sponsor Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) Intraocular pressure measurement in both eyes using the Goldman applanation tonometer. 6 months
Primary 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. 6 months
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