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Search / Trial NCT05039684

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

Launched by INSTITUTO UNIVERSITARIO DE OFTALMOBIOLOGÍA APLICADA (INSTITUTE OF APPLIED OPHTHALMOBIOLOGY) - IOBA · Sep 1, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Glaucoma Prostaglandin Ocular Hypertension Biomarker Inflammation Confocal In Vivo Microscopy Cornea Tear Film Conjunctiva Impression Cytology

ClinConnect Summary

This clinical trial is studying how different eye drops used to treat glaucoma and ocular hypertension affect the surface of the eye. Glaucoma and ocular hypertension are conditions where the pressure inside the eye is too high, which can lead to vision problems. The trial will compare the effects of three types of eye drops: tafluprost (which does not contain preservatives) and two versions of latanoprost (one with preservatives and one without). Researchers want to see if these medications change the eye's surface and how they influence inflammation in patients who have been using these treatments for at least three months.

To be eligible for the study, participants should be at least 18 years old and have a diagnosis of primary open-angle glaucoma or ocular hypertension. They must have been using one of the eye drops for at least three months, or they can be treatment-naive (not currently using any medication for their eye condition). Participants will undergo tests to evaluate their eye health, and there are a few exclusions, such as recent eye surgery or certain other eye conditions. This research aims to improve our understanding of how these treatments impact eye health, which can help doctors provide better care for patients with these conditions.

Gender

ALL

Eligibility criteria

  • 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.

About Instituto Universitario De Oftalmobiología Aplicada (Institute Of Applied Ophthalmobiology) Ioba

The Instituto Universitario de Oftalmobiología Aplicada (IOBA) is a leading research institution dedicated to advancing the field of ophthalmology through innovative clinical trials and applied research. Based at the intersection of academia and healthcare, IOBA focuses on developing cutting-edge therapies and diagnostic tools for ocular diseases, aiming to enhance patient outcomes and contribute to the global body of knowledge in vision science. With a team of expert researchers and clinicians, IOBA fosters collaboration and knowledge transfer, striving to translate scientific advancements into practical solutions for eye health.

Locations

Valladolid, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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