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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
IOBA
RECRUITING
Valladolid
Contact Information
Primary
Carolina Ossa Calderon, MD
cossac@ioba.med.uva.es
983184734
Backup
Francisco Blazquez Arauzo, MD, MsC
blazquez@ioba.med.uva.es
983184734
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
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
Sponsors
Leads: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators: Hospital Clínico Universitario de Valladolid

This content was sourced from clinicaltrials.gov

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