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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

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

NCT ID

NCT03204487

First Posted

June 23, 2017

Last Updated

August 22, 2017

Sponsor

Ordination Dr. Hommer

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

Studies a U.S. FDA-regulated Device Product

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

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

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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