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

NCT05039684 | Recruiting

• 1 other identifier: IOBA-2021-44
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Keywords

glaucoma; prostaglandin; ocular hypertension; biomarker; inflammation; confocal in-vivo microscopy; cornea; tear film; conjunctiva; impression cytology

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with ocular hypertension or primary open angle glaucoma

You may qualify if:

• Patients with primary open angle glaucoma or ocular hypertension as defined in Early Manifest Glaucoma Trial
• \> 18 years old
• Signed informed consent
• 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.

You may not qualify if:

• Ocular surgery in the previous 6 months.
• Any topical treatment other than the evaluated in this study in the last 3 months.
• Use of contact lenses in the las 4 weeks.
• Any mental or physical disease that may prevent performing the required tests for the study.

Sponsors & Collaborators

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

Study Sites (1)

IOBA

Valladolid, 47011, Spain

RECRUITING

Biospecimen

Retention: NONE RETAINED

A 1-2 microL tear sample. Conjunctival impression cytology

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma; Inflammation; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carolina Ossa Calderon, MD

CONTACT

983184734; cossac@ioba.med.uva.es

Francisco Blazquez Arauzo, MD, MsC

CONTACT

983184734; blazquez@ioba.med.uva.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 9, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)