Inflammatory Biomarkers in Ocular Surface in Primary Open Angle Glaucoma or Ocular Hypertension Under Topical Prostaglandins

Inflammatory Biomarkers in Ocular Surface in Patients With Primary Open Angle Glaucoma and Ocular Hypertension Under Topical Prostaglandin Therapy

Glaucoma is a chronic optic neuropathy whose main modifiable risk factor is an abnormally elevated intraocular pressure. The aim of glaucoma treatment is to slow the progression of the disease by reducing intraocular pressure.

Prostaglandin derivatives are the most effective topical drugs in reducing intraocular pressure (IOP). Among these, latanoprost was the first agent of this type to be approved for use in patients with glaucoma or ocular hypertension.

These eye drops are available with and without preservatives. There are two commercial brands in our environment, Xalatan®, which contains 0.005% latanoprost and 0.2 mg/ml benzalkonium chloride (BAK) and Monoprost®, which contains the same amount of latanoprost but does not carry a preservative. The prostaglandin analog with a lower concentration of active ingredient available in Spain without preservative is tafluprost 0.0015%, commercially available under the name Saflutan®.

The long-term use of hypotensive eye drops with preservatives generates changes in the ocular surface, such as instability of the tear film, conjunctival inflammation, subconjunctival fibrosis, apoptosis of the conjunctival epithelium and deterioration of the corneal surface, causing symptoms such as stinging, tearing, sensation foreign body, photophobia and blurred vision.

This research will evaluate the changes in the ocular surface and in the expression of inflammatory molecules that occur in the conjunctiva in patients with a diagnosis of glaucoma and ocular hypertension who are under ocular hypotensive treatment with tafluprost, comparing it with the two commercial preparations of latanoprost.

These three groups of patients will have a control group of patients with a diagnosis of ocular hypertension who will not have any topical hypotensive medication.

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Glaucoma, Open-Angle

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Carolina Ossa Calderon, MD; Phone Number: 983184734; Email: cossac@ioba.med.uva.es
• Study Contact Backup: Name: Francisco Blazquez Arauzo, MD, MsC; Phone Number: 983184734; Email: blazquez@ioba.med.uva.es

Study Locations

• Spain
  • Valladolid, Spain, 47011
    • Recruiting
    • IOBA
    • Contact: Francisco Blazquez Arauzo, MD, MsC; Phone Number: 983184734; Email: blazquez@ioba.med.uva.es
    • Contact: Carolina Ossa Calderon, MD, MsC; Phone Number: 983184734; Email: cossac@ioba.med.uva.es
    • Sub-Investigator: Carolina Ossa Calderon, MD
    • Principal Investigator: Ramon Juberias Sanchez, MD, PhD
    • Sub-Investigator: Margarita Calonge Cano, MD, PhD
    • Sub-Investigator: Yolanda Diebold Luque, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with ocular hypertension or primary open angle glaucoma

Description

Inclusion Criteria:

• Patients with primary open angle glaucoma or ocular hypertension as defined in Early Manifest Glaucoma Trial
• > 18 years old
• Signed informed consent
• 3 or more months under monotherapy treatment with tafluprost 0.0015%, latanoprost 0.005% with BAK 0.2mg/ml or latanoprost 0.005%.
• Untreated patients with ocular hypertension must be treatment naïve for the pathology.
• No presence or history of previous ocular diseases other than glaucoma or ocular hypertension, started before the use of hypotensive medication.

Exclusion Criteria:

• Ocular surgery in the previous 6 months.
• Any ocular surface disease not related to inclusion criteria or related issues active within the last 6 months.
• Any topical treatment other than the evaluated in this study in the last 3 months.
• In case of artificial teardrops use, only non conservative ones are allowed, with no more than 4 times per day use, and treatment must be suspended 5 days before inclusion.
• Use of contact lenses in the las 4 weeks.
• Any mental or physical disease that may prevent performing the required tests for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Primary open angle glaucoma / ocular hypertension - Treatment with Xalatan; Patients with primary open angle glaucoma or ocular hypertension treated with Xalatan
Primary open angle glaucoma / ocular hypertension - Treatment with Monoprost; Patients with primary open angle glaucoma or ocular hypertension treated with Monoprost
Primary open angle glaucoma / ocular hypertension - Treatment with Saflutan; Patients with primary open angle glaucoma or ocular hypertension treated with Saflutan
Ocular hypertension - No treatment; Patients ocular hypertension untreated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory response in ocular surface secondary to prostaglandin use	Presence of inflammatory cytokines in ocular surface	24 hours
Conjunctival cell phenotype and inflammatory infiltration	Conjunctival cell phenotype assessment by conjunctival in vivo confocal microscopy	24 hours
Changes in oxidative stress in the tear film	Changes in oxidative stress at conjunctiva secondary to prostaglandin treatment	24 hours

Collaborators and Investigators

• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Collaborators: Hospital Clínico Universitario de Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: biomarker; inflammation; impression cytology; ocular hypertension; cornea; tear film; glaucoma; prostaglandin; conjunctiva; confocal in-vivo microscopy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: IOBA-2021-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No