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Trial record 38 of 81025 for:    measured

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

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ClinicalTrials.gov Identifier: NCT02585375
Recruitment Status : Recruiting
First Posted : October 23, 2015
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief 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.


Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Preservative-free latanoprost 50µg/ml Drug: Preserved latanoprost 0.005% Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT
Study Start Date : April 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Tears
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: Patients with glaucoma or ocular hypertension 1
35 patients with glaucoma or ocular hypertension
Drug: Preservative-free latanoprost 50µg/ml
Active Comparator: Patients with glaucoma or ocular hypertension 2
35 patients with glaucoma or ocular hypertension
Drug: Preserved latanoprost 0.005%



Primary Outcome Measures :
  1. Tear film thickness measured with high resolution optical coherence tomography (OCT) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Tear Break Up Time [ Time Frame: 6 months ]
  2. Tear Film Osmolarity [ Time Frame: 6 months ]
  3. Conjunctival hyperemia score [ Time Frame: 6 months ]
  4. Staining of the cornea with fluorescein according to Oxford scale [ Time Frame: 6 months ]
  5. Impression cytology according to Haller-Schober scale 2006 [ Time Frame: 6 months ]
  6. Schirmer 1 test [ Time Frame: 6 months ]
  7. Ocular Surface Disease Index score [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585375


Contacts
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Contact: Gerhard Garhofer, MD +43 1 40400 ext 29810 gerhard.garhoefer@meduniwien.ac.at
Contact: Katarzyna J Witkowska, MD, Phd +43 1 40400 ext 29810 katarzyna.witkowska@meduniwien.ac.at

Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhofer, MD    00431 40400 ext 29810    gerhard.garhoefer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02585375     History of Changes
Other Study ID Numbers: OPHT-081214
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Latanoprost
Antihypertensive Agents