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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Preservative-free latanoprost 50µg/ml
Preserved latanoprost 0.005%
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with glaucoma or ocular hypertension 1

Patients with glaucoma or ocular hypertension 2

Arm Description

35 patients with glaucoma or ocular hypertension

35 patients with glaucoma or ocular hypertension

Outcomes

Primary Outcome Measures

Tear film thickness measured with high resolution optical coherence tomography (OCT)

Secondary Outcome Measures

Tear Break Up Time
Tear Film Osmolarity
Conjunctival hyperemia score
Staining of the cornea with fluorescein according to Oxford scale
Impression cytology according to Haller-Schober scale 2006
Schirmer 1 test
Ocular Surface Disease Index score

Full Information

First Posted
April 26, 2015
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02585375
Brief Title
Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT
Official Title
Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2015 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with glaucoma or ocular hypertension 1
Arm Type
Experimental
Arm Description
35 patients with glaucoma or ocular hypertension
Arm Title
Patients with glaucoma or ocular hypertension 2
Arm Type
Active Comparator
Arm Description
35 patients with glaucoma or ocular hypertension
Intervention Type
Drug
Intervention Name(s)
Preservative-free latanoprost 50µg/ml
Intervention Type
Drug
Intervention Name(s)
Preserved latanoprost 0.005%
Primary Outcome Measure Information:
Title
Tear film thickness measured with high resolution optical coherence tomography (OCT)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tear Break Up Time
Time Frame
6 months
Title
Tear Film Osmolarity
Time Frame
6 months
Title
Conjunctival hyperemia score
Time Frame
6 months
Title
Staining of the cornea with fluorescein according to Oxford scale
Time Frame
6 months
Title
Impression cytology according to Haller-Schober scale 2006
Time Frame
6 months
Title
Schirmer 1 test
Time Frame
6 months
Title
Ocular Surface Disease Index score
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhofer, MD
Phone
+43 1 40400
Ext
29810
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna J Witkowska, MD, Phd
Phone
+43 1 40400
Ext
29810
Email
katarzyna.witkowska@meduniwien.ac.at
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhofer, MD
Phone
00431 40400
Ext
29810
Email
gerhard.garhoefer@meduniwien.ac.at

12. IPD Sharing Statement

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

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