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

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Tafluprost 15µg/ml
Sponsored by
Ordination Dr. Hommer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring tear film thickness, ocular surface disease, OCT

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 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

Sites / Locations

  • Ordination Dr. Hommer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with glaucoma or ocular hypertension

Arm Description

Outcomes

Primary Outcome Measures

Tear film thickness
Measurement of tear film thickness using OCT

Secondary Outcome Measures

Intraocular pressure (IOP)
Measurement of IOP using Goldmann applanation tonometry
Ocular Surface Disease Index (OSDI)
Subjective symptom questionnaire
Dry-Eye Related Quality of Life Score (DEQS)
Subjective symptom questionnaire
Tear Break Up Time (BUT)
Assessment of BUT in seconds using fluorescein eye drops at the slit lamp.
Schirmer Test 1
Wetting of Schirmer test strips within 5 minutes without topical anaesthesia.
Tear film osmolarity
Tear film osmolarity will be assessed using the TearLab Osmolarity Test.
Corneal fluorescein staining
Corneal fluorescein staining will be assessed after instillation of fluorescein eye drops at the slit lamp.

Full Information

First Posted
June 23, 2017
Last Updated
August 22, 2017
Sponsor
Ordination Dr. Hommer
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1. Study Identification

Unique Protocol Identification Number
NCT03204487
Brief Title
A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 10, 2016 (Actual)
Primary Completion Date
April 25, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ordination Dr. Hommer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension
Keywords
tear film thickness, ocular surface disease, OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with glaucoma or ocular hypertension
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tafluprost 15µg/ml
Intervention Description
Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien)
Primary Outcome Measure Information:
Title
Tear film thickness
Description
Measurement of tear film thickness using OCT
Time Frame
Change from baseline tear film thickness at 4 and 12 weeks
Secondary Outcome Measure Information:
Title
Intraocular pressure (IOP)
Description
Measurement of IOP using Goldmann applanation tonometry
Time Frame
Change from baseline IOP at 4 and 12 weeks
Title
Ocular Surface Disease Index (OSDI)
Description
Subjective symptom questionnaire
Time Frame
Change from baseline OSDI at 4 and 12 weeks
Title
Dry-Eye Related Quality of Life Score (DEQS)
Description
Subjective symptom questionnaire
Time Frame
Change from baseline DEQS at 4 and 12 weeks
Title
Tear Break Up Time (BUT)
Description
Assessment of BUT in seconds using fluorescein eye drops at the slit lamp.
Time Frame
Change from baseline BUT at 4 and 12 weeks
Title
Schirmer Test 1
Description
Wetting of Schirmer test strips within 5 minutes without topical anaesthesia.
Time Frame
Change from Schirmer Test 1 at 4 and 12 weeks
Title
Tear film osmolarity
Description
Tear film osmolarity will be assessed using the TearLab Osmolarity Test.
Time Frame
Change from baseline tear film osmolarity at 4 and 12 weeks
Title
Corneal fluorescein staining
Description
Corneal fluorescein staining will be assessed after instillation of fluorescein eye drops at the slit lamp.
Time Frame
Change from baseline corneal fluorescein staining at 4 and 12 weeks

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 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
Facility Information:
Facility Name
Ordination Dr. Hommer
City
Vienna
ZIP/Postal Code
1080
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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