Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT

  • STATUS
    Recruiting
  • End date
    Sep 2, 2023
  • participants needed
    70
  • sponsor
    Medical University of Vienna
Updated on 21 April 2022
hypertension
screening examination
prostaglandin
glaucoma
optical coherence tomography
ophthalmic solution
brimonidine tartrate ophthalmic solution
latanoprost
antihypertensives
ocular surface disease
benzalkonium chloride
pigmentary glaucoma
primary open angle glaucoma

Summary

Topical antihypertensive eye drops are a key element of modern antiglaucoma treatment. Most of these eye drops contain preservatives to allow for the use of multi-dose containers. In the recent years evidence has, however, accumulated that these preservatives may induce ocular surface disease (OSD). This is particularly true for the most widely used preservative, benzalkonium chloride (BAK). Whereas this is well documented in many in vitro and animal studies, evidence from clinical trials is sparse. The only randomized masked study that showed superiority is a pivotal company-sponsored study indicating improved tolerability and reduced hyperemia of unpreserved versus preserved latanoprost eye drops.

The investigators have recently introduced an optical coherence tomography (OCT) technology that provides a resolution as high as 1.2 µm for the human cornea. Using this technology the investigators were able to show that tear film thickness (TFT) is negatively correlated with symptoms of OSD. Changes in TFT can be assessed with very high sensitivity below the level of resolution as also evident from studies after administration of lubricants.

In the present study, the investigators hypothesize that switching glaucoma patients from preserved prostaglandin analogues to unpreserved latanoprost is associated with an increase in TFT as measured with OCT. As a control the investigators will use preserved latanoprost and the study hypothesis will be tested in a randomized, controlled, single-masked parallel group design. TFT is chosen as main outcome variable, standard measures for signs and symptoms of OSD are selected as secondary outcomes. The present study may provide valuable information on the superiority of unpreserved versus preserved therapy.

Details
Condition Glaucoma, Ocular Hypertension
Treatment Preservative-free latanoprost 50µg/ml, Preserved latanoprost 0.005%
Clinical Study IdentifierNCT02585375
SponsorMedical University of Vienna
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women aged over 18 years
Diagnosed primary open angle glaucoma treated with preserved prostaglandin analogues containing at least 0.001% BAK for at least 6 months OR
Patients with ocular hypertension treated with preserved prostaglandin analogues containing at least 0.001% BAK for at least 6 months
IOP ≤ 21 mmHg in the study eye at the screening examination (under treatment)
Mean tear film thickness at the screening visit < 4µm in the study eye

Exclusion Criteria

Participation in a clinical trial in the 3 weeks before the screening visit
Severe visual field loss as defined as an MD of -15 or worse in the study eye
Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
Sjögren's syndrome
Stevens-Johnson syndrome
Presence or history of a severe ocular condition that will interfere with the study aim as judged by the clinical investigator
Presence or history of allergic conjunctivitis
Treatment with corticosteroids in the 4 weeks preceding the study
Wearing of contact lenses
Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except glaucoma medication or topical lubricants
Ocular infection
Ocular surgery in the 6 months preceding the study (except laser trabeculoplasty)
Pregnancy, planned pregnancy or lactating
Contraindication against the use of topical prostaglandin therapy
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