Glaucoma, Open-AnglePhase 4NCT03204487
A Study on the Effect of Changing From Preserved Prostaglandin Formulations to Preservative Free Tafluprost on Tear Film Thickness
A Phase 4 study testing Tafluprost 15µg/ml in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Ordination Dr. Hommer at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- Tafluprost 15µg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 10 May 2016to 30 Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- Tafluprost 15µg/ml
- Keywords
- tear film thickness, ocular surface disease, OCT
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafluprost 15µg/mlDrug
Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp \& Dohme, Wien)
| Study group | Role | What they receive |
|---|---|---|
| Patients with glaucoma or ocular hypertension | Experimental | Not described Receives: Drug: Tafluprost 15µg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness
Measurement of tear film thickness using OCT
Measured: Change from baseline tear film thickness at 4 and 12 weeks
Secondary outcomes (7)
Intraocular pressure (IOP)
Measurement of IOP using Goldmann applanation tonometry
Measured: Change from baseline IOP at 4 and 12 weeks
Ocular Surface Disease Index (OSDI)
Subjective symptom questionnaire
Measured: Change from baseline OSDI at 4 and 12 weeks
Dry-Eye Related Quality of Life Score (DEQS)
Subjective symptom questionnaire
Measured: Change from baseline DEQS at 4 and 12 weeks
Tear Break Up Time (BUT)
Assessment of BUT in seconds using fluorescein eye drops at the slit lamp.
Measured: Change from baseline BUT at 4 and 12 weeks
Schirmer Test 1
Wetting of Schirmer test strips within 5 minutes without topical anaesthesia.
Measured: Change from Schirmer Test 1 at 4 and 12 weeks
Tear film osmolarity
Tear film osmolarity will be assessed using the TearLab Osmolarity Test.
Measured: Change from baseline tear film osmolarity at 4 and 12 weeks
Corneal fluorescein staining
Corneal fluorescein staining will be assessed after instillation of fluorescein eye drops at the slit lamp.
Measured: Change from baseline corneal fluorescein staining at 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start10 May 2016
- Primary completion25 Apr 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordination Dr. Hommer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204487
- Sponsor's protocol ID
- HOM1-2015
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03204487
- Acronym / sponsor ID
- HOM1-2015
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- tear film thickness, ocular surface disease, OCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ordination Dr. HommerUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with glaucoma or ocular hypertension | Experimental | Drug: Tafluprost 15µg/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafluprost 15µg/mlTafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp \& Dohme, Wien) | Drug | Patients with glaucoma or ocular hypertension |
Primary outcome
Tear film thickness
Time frame: Change from baseline tear film thickness at 4 and 12 weeks
Measurement of tear film thickness using OCT
7 secondary outcomes
Intraocular pressure (IOP)
Time frame: Change from baseline IOP at 4 and 12 weeks
Ocular Surface Disease Index (OSDI)
Time frame: Change from baseline OSDI at 4 and 12 weeks
Dry-Eye Related Quality of Life Score (DEQS)
Time frame: Change from baseline DEQS at 4 and 12 weeks
Tear Break Up Time (BUT)
Time frame: Change from baseline BUT at 4 and 12 weeks
Schirmer Test 1
Time frame: Change from Schirmer Test 1 at 4 and 12 weeks
Tear film osmolarity
Time frame: Change from baseline tear film osmolarity at 4 and 12 weeks
Corneal fluorescein staining
Time frame: Change from baseline corneal fluorescein staining at 4 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tafluprost 15µg/ml in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Ordination Dr. Hommer at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film thickness (time frame: Change from baseline tear film thickness at 4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.