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

Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other)
Overall Status
Recruiting
CT.gov ID
NCT05039684
Collaborator
Hospital Clínico Universitario de Valladolid (Other)
40
1
14
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Inflammatory Biomarkers in Ocular Surface in Patients With Primary Open Angle Glaucoma and Ocular Hypertension Under Topical Prostaglandin Therapy
    Actual Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory response in ocular surface secondary to prostaglandin use [24 hours]

      Presence of inflammatory cytokines in ocular surface

    2. Conjunctival cell phenotype and inflammatory infiltration [24 hours]

      Conjunctival cell phenotype assessment by conjunctival in vivo confocal microscopy

    3. Changes in oxidative stress in the tear film [24 hours]

      Changes in oxidative stress at conjunctiva secondary to prostaglandin treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IOBA Valladolid Spain 47011

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
    ClinicalTrials.gov Identifier:
    NCT05039684
    Other Study ID Numbers:
    • IOBA-2021-44
    First Posted:
    Sep 9, 2021
    Last Update Posted:
    Jan 31, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 31, 2022