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NCT Number: NCT03204487

A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness

Studies have shown that ocular surface disease (OSD) is common among patients with glaucoma with a prevalence of 50% or more. The percentage of affected patients appears to increase with increasing number of topical anti-glaucoma products instilled. Both pre-clinical and clinical work has indicated that the preservatives used in anti-glaucoma drops, particularly benzalkonium chloride, are mainly responsible for this detrimental effect. As such more and more anti-glaucoma drugs without preservatives entered the market.

To prove that switching from preserved to unpreserved antiglaucoma medication improves the signs and symptom of OSD is, however, not easy. This is on the one hand related to the physiological variability of these parameters over time and on the other hand to the poor association between signs and symptoms. Recently, a new method for measuring tear film thickness (TFT) using ultra-high resolution optical coherence tomography (OCT) has been introduced. Using this method, it has been shown that there is a correlation between reduced TFT and OSD symptoms. In the present study, it is hypothesized that changing patients who are on preserved prostaglandin formulations to preservative free tafluprost may be associated with an increase in TFT.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ordination Dr. Hommer

Vienna, 1080, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged over 18 years
  • Diagnosed primary open angle glaucoma treated with preserved prostaglandins for at least 6 months OR
  • Patients with ocular hypertension treated with preserved prostaglandins for at least 6 months
  • IOP ≤ 21 mmHg in the study eye at the screening examination (under treatment)
  • Mean TFT at the screening visit ≤ 6µm in the study eye
  • At least 2 symptoms of dry eye syndrome in the study eye (itching, stinging, blurred vision, foreign body sensation, debris, conjunctival redness) since at least one month
  • Tear break up time ≤ 10sec

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

Treatment and study plan

Tafluprost 15µg/ml

Drug

Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien)

Primary outcomes

  1. Tear film thickness

    Time frame: Change from baseline tear film thickness at 4 and 12 weeks

    Measurement of tear film thickness using OCT

Secondary outcomes

  1. Intraocular pressure (IOP)

    Time frame: Change from baseline IOP at 4 and 12 weeks

    Measurement of IOP using Goldmann applanation tonometry

  2. Ocular Surface Disease Index (OSDI)

    Time frame: Change from baseline OSDI at 4 and 12 weeks

    Subjective symptom questionnaire

  3. Dry-Eye Related Quality of Life Score (DEQS)

    Time frame: Change from baseline DEQS at 4 and 12 weeks

    Subjective symptom questionnaire

  4. Tear Break Up Time (BUT)

    Time frame: Change from baseline BUT at 4 and 12 weeks

    Assessment of BUT in seconds using fluorescein eye drops at the slit lamp.

  5. Schirmer Test 1

    Time frame: Change from Schirmer Test 1 at 4 and 12 weeks

    Wetting of Schirmer test strips within 5 minutes without topical anaesthesia.

  6. Tear film osmolarity

    Time frame: Change from baseline tear film osmolarity at 4 and 12 weeks

    Tear film osmolarity will be assessed using the TearLab Osmolarity Test.

  7. Corneal fluorescein staining

    Time frame: Change from baseline corneal fluorescein staining at 4 and 12 weeks

    Corneal fluorescein staining will be assessed after instillation of fluorescein eye drops at the slit lamp.

Sponsors and collaborators

Lead sponsor

Ordination Dr. Hommer

Other

Registry information

Official study title

An Open, Non-randomized Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma on Tear Film Thickness

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2017
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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