Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT05039684

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

Led by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Updated on 2024-10-31

40

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

I

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Lead Sponsor

H

Hospital Clínico Universitario de Valladolid

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary open angle glaucoma or ocular hypertension as defined in Early Manifest Glaucoma Trial
  • Age over 18 years
  • Signed informed consent
  • At least 3 months of monotherapy treatment with tafluprost 0.0015%, latanoprost 0.005% with BAK 0.2 mg/ml, or latanoprost 0.005%
  • Untreated patients with ocular hypertension must be treatment-naïve
  • No history of ocular diseases other than glaucoma or ocular hypertension before starting hypotensive medication
Not Eligible

You will not qualify if you...

  • Ocular surgery within the previous 6 months
  • Any active ocular surface disease not related to glaucoma or ocular hypertension in the last 6 months
  • Use of topical treatments other than the study drugs in the last 3 months
  • Use of artificial tears more than 4 times per day or with preservatives; must stop use 5 days before inclusion if used
  • Contact lens use in the last 4 weeks
  • Any mental or physical condition preventing required study tests

AI-Screening

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Trial Site Locations

Total: 1 location

1

IOBA

Valladolid, Spain, 47011

Actively Recruiting

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Research Team

C

Carolina Ossa Calderon, MD

CONTACT

F

Francisco Blazquez Arauzo, MD, MsC

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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