GlaucomaPhase 4NCT02585375
Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT
A Phase 4 study testing Preservative-free latanoprost 50µg/ml and Preserved latanoprost 0.005% in people with Glaucoma and Ocular Hypertension, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Preservative-free latanoprost 50µg/ml and Preserved latanoprost 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 17 Sep 2015to 2 Sep 2023
- 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 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
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.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhofer, MD, 00431 40400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at
About this study
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.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Preservative-free latanoprost 50µg/ml, Preserved latanoprost 0.005%
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative-free latanoprost 50µg/mlDrug
Preserved latanoprost 0.005%Drug
| Study group | Role | What they receive |
|---|---|---|
| Patients with glaucoma or ocular hypertension 1 | Experimental | 35 patients with glaucoma or ocular hypertension Receives: Drug: Preservative-free latanoprost 50µg/ml |
| Patients with glaucoma or ocular hypertension 2 | Active comparator | 35 patients with glaucoma or ocular hypertension Receives: Drug: Preserved latanoprost 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear film thickness measured with high resolution optical coherence tomography (OCT)
Measured: 6 months
Secondary outcomes (7)
Tear Break Up Time
Measured: 6 months
Tear Film Osmolarity
Measured: 6 months
Conjunctival hyperemia score
Measured: 6 months
Staining of the cornea with fluorescein according to Oxford scale
Measured: 6 months
Impression cytology according to Haller-Schober scale 2006
Measured: 6 months
Schirmer 1 test
Measured: 6 months
Ocular Surface Disease Index score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start17 Sep 2015
- Primary completionSep 2023 (estimated)
- Study completion2 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585375
- Sponsor's protocol ID
- OPHT-081214
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latanoprost Preserved Versus Unpreserved: Effect on Tear Film Thickness as Measured With OCT
- ClinicalTrials.gov ID
- NCT02585375
- Acronym / sponsor ID
- OPHT-081214
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 2 Sep 2023 (estimated)
- First posted
- 23 Oct 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with glaucoma or ocular hypertension 1 | Experimental | Drug: Preservative-free latanoprost 50µg/ml35 patients with glaucoma or ocular hypertension |
| Patients with glaucoma or ocular hypertension 2 | Active comparator | Drug: Preserved latanoprost 0.005%35 patients with glaucoma or ocular hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Preservative-free latanoprost 50µg/ml | Drug | Patients with glaucoma or ocular hypertension 1 |
| Preserved latanoprost 0.005% | Drug | Patients with glaucoma or ocular hypertension 2 |
Primary outcome
Tear film thickness measured with high resolution optical coherence tomography (OCT)
Time frame: 6 months
7 secondary outcomes
Tear Break Up Time
Time frame: 6 months
Tear Film Osmolarity
Time frame: 6 months
Conjunctival hyperemia score
Time frame: 6 months
Staining of the cornea with fluorescein according to Oxford scale
Time frame: 6 months
Impression cytology according to Haller-Schober scale 2006
Time frame: 6 months
Schirmer 1 test
Time frame: 6 months
Ocular Surface Disease Index score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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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.
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 Preservative-free latanoprost 50µg/ml and Preserved latanoprost 0.005% in people with Glaucoma and Ocular Hypertension, run by Medical University of Vienna 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 5 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhofer, MD (+43 1 40400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film thickness measured with high resolution optical coherence tomography (OCT) (time frame: 6 months). 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 7 Apr 2022.