Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives

NCT05319470 | Completed

• 1 other identifier: ES3/Th11/03-02-2022
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Glaucoma; Drugs; Ocular Surface Disease

Keywords

glaucoma; travoprost; prostaglandin without preservatives

Outcome Measures

Primary Outcomes (2)

• Intraocular Pressure (IOP)

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

  6 months

• 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

Study Arms (1)

Study Group

100 patients with diagnosed glaucoma receiving travoprost without preservatives

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

Interventions

Intraocular pressure (IOP) DIAGNOSTIC_TEST

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

Study Group

Tear Break-up Time (TBUT) DIAGNOSTIC_TEST

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

Study Group

Conjuctival Hyperemia DIAGNOSTIC_TEST

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

Study Group

Schirmer Test DIAGNOSTIC_TEST

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

Study Group

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.

Study Group

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult glaucoma patients already under treatment with travoprost without preservatives.

You may qualify if:

• Patients with glaucoma treated with travoprost without preservatives.

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Intraocular Pressure; Wettability; Visual Fields

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena; Hydrophobic and Hydrophilic Interactions; Chemical Phenomena; Surface Properties

Study Officials

• Georgios Labiris, MD,PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: March 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: May 15, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

GR (1)