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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorInstituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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.

Trial population

Adult patients with ocular hypertension or primary open angle glaucoma

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 4 trial groups
Group A: Primary open angle glaucoma / ocular hypertension - Treatment with Xalatan
Group B: Primary open angle glaucoma / ocular hypertension - Treatment with Monoprost
Group C: Primary open angle glaucoma / ocular hypertension - Treatment with Saflutan
Group D: Ocular hypertension - No treatment

Trial outcomes

Primary outcomes

1

Inflammatory response in ocular surface secondary to prostaglandin use

Presence of inflammatory cytokines in ocular surface

Time frame
24 hours
2

Conjunctival cell phenotype and inflammatory infiltration

Conjunctival cell phenotype assessment by conjunctival in vivo confocal microscopy

Time frame
24 hours
3

Changes in oxidative stress in the tear film

Changes in oxidative stress at conjunctiva secondary to prostaglandin treatment

Time frame
24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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