Ocular HypertensionPhase 4NCT01369771
The Effects of Preservative-free Prostaglandin Eye Drops in Sign and Symptoms on the Eyes of Patients With Glaucoma
A Phase 4 study testing Tafluprost 0.0015% in people with Ocular Hypertension and Open-Angle Glaucoma, run by FinnMedi Oy at 1 site in Finland.
Trial summary
The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ocular Hypertension, Open-Angle Glaucoma
- What is being tested?
- Tafluprost 0.0015%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2010to Jun 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided a written informed consent
- Aged 18 years or more
- A diagnosis of ocular hypertension or open-angle glaucoma (either POAG or capsular glaucoma) in one or both eyes, for which the patient has been regularly using latanoprost 0.005% (Xalatan®) for at least six months before Screening (confirmed in anamnesis)
- In the Screening visit evaluation, the presence of:
- At least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation OR One ocular symptom of at least mild severity (grade ≥ 2) upon non-instillation AND
- At least one of the following ocular signs in either eye with prior treatment:
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- Fluorescein tear break-up time (fBUT): less than 10 seconds
- Corneal and conjunctival fluorescein staining:
- Corneal fluorescein staining score of at least grade I OR Combined nasal and temporal staining scores of at least grade II Blepharitis: of at least mild severity (grade ≥ 1) Conjunctival redness/hyperemia: of at least mild severity (grade 1) Tear production: 10 mm or less on Schirmer test
- A best corrected ETDRS visual acuity score of +0.6 logMAR or better in both eyes
- Negative pregnancy test result at the screening visit, or, consistently and correctly used reliable method of contraception during the study
- Are willing to follow instructions
Who cannot join
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
- Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery
- IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit
- Use of preserved eye drops (other than latanoprost) including artificial tears at screening or within two weeks prior to screening visit
- Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular glaucoma in either eye
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- Suspected contraindication to tafluprost therapy (hypersensitivity to tafluprost or any of the excipients)
- Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening in eye(s) to be treated with study medication
- Use of contact lenses at Screening or during the study
- Any ocular (e.g. aphakia, pseudophakia with torn posterior lens capsule2 or anterior chamber lenses,known risk factors for cystoid macular oedema or iritis/uveitis), systemic or psychiatric disease/condition (e.g.uncontrolled arterial hypertension, diabetes) that may put the patient at a significant risk or may confound the study results or may interfere significantly with the patient's participation in the study as judged by the investigator
- Current alcohol or drug abuse
- Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
Finland1 site
FinnMedi Oy, Clinical Trial Center
Tampere, Pirkanmaa District, 33520
About this study
Official title: An Open-label, Phase IV, Pilot Study, to Evaluate Confocal Microscopic Findings of Cornea, Ocular Signs and Symptoms in Patients With OH or OAG Switching From Latanoprost 0.005% to Preservative Free Tafluprost 0.0015% Eye Drops
The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months.
Read the detailed description
Primary outcome measures:
- Change from screening in corneal confocal microscopic findings at month 12
- Change from screening in ocular symptoms upon non-instillation at month 12
- Change from screening in ocular signs at month 12 Safety and QoL variables:
- Descriptive statistics, identification of change(s) from screening
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Being tested
- Tafluprost 0.0015%
- Keywords
- Confocal microscopic findings, Ocular Hypertension, Open-Angle Glaucoma, Preservative-free eye drops
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafluprost 0.0015%Drug
Also called Taflotan®, Taflotan sine®, Saflutan®, Saflutan Conserveermiddelvrij®
Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Tafluprost 0.0015% | Experimental | Open, one arm study. Patients who have been using latanoprost 0.005% eye drops (Xalatan®) as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost to the assigned preservative-free tafluprost 0.0015% (Taflotan®)eye drops for twelve (12) months. Receives: Drug: Tafluprost 0.0015% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from screening in corneal confocal microscopic findings at month 12
Measured: Baseline and Month 12
Secondary outcomes (1)
Change from screening in ocular symptoms and signs upon non-instillation
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- FinnMedi Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tampere University, The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District
- Responsible party
- Sponsor
- Investigators
- Hannu Uusitalo, MD, PhD, Principal investigator, Clinical Trial Center, FinnMedi Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369771
- Sponsor's protocol ID
- S001-2010
- Other IDs
- 2010-021039-14
- Status last verified
- Oct 2014
- First submitted
- 5 Jul 2010
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase IV, Pilot Study, to Evaluate Confocal Microscopic Findings of Cornea, Ocular Signs and Symptoms in Patients With OH or OAG Switching From Latanoprost 0.005% to Preservative Free Tafluprost 0.0015% Eye Drops
- ClinicalTrials.gov ID
- NCT01369771
- Acronym / sponsor ID
- S001-2010
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Keywords
- Confocal microscopic findings, Ocular Hypertension, Open-Angle Glaucoma, Preservative-free eye drops
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- FinnMedi OyIndustry (pharma, biotech, devices)
- Collaborators
- Tampere University, The Laboratory and Pharmacy Public Utility of the Pirkanmaa Hospital District
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Jun 2011 (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.
The objective of this study is to investigate corneal confocal microscopic findings, ocular signs and symptoms in patients on treatment with the preserved prostaglandin analogue latanoprost 0.005% eye drops (Xalatan®) and after the switch to preservative-free prostaglandin analog tafluprost 0.0015% eye drops (Taflotan®). Patients who have been using latanoprost as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost 0.005% eye drops to the assigned preservative-free tafluprost 0.0015% eye drops for twelve (12) months.
Detailed description
Primary outcome measures:
- Change from screening in corneal confocal microscopic findings at month 12
- Change from screening in ocular symptoms upon non-instillation at month 12
- Change from screening in ocular signs at month 12 Safety and QoL variables:
- Descriptive statistics, identification of change(s) from screening
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tafluprost 0.0015% | Experimental | Drug: Tafluprost 0.0015%Open, one arm study. Patients who have been using latanoprost 0.005% eye drops (Xalatan®) as their prior medication (at least 6 months) and who fulfil all the inclusion criteria including the specified ocular symptoms and signs, will switch from latanoprost to the assigned preservative-free tafluprost 0.0015% (Taflotan®)eye drops for twelve (12) months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have provided a written informed consent
- Aged 18 years or more
- A diagnosis of ocular hypertension or open-angle glaucoma (either POAG or capsular glaucoma) in one or both eyes, for which the patient has been regularly using latanoprost 0.005% (Xalatan®) for at least six months before Screening (confirmed in anamnesis)
- In the Screening visit evaluation, the presence of:
- At least two ocular symptoms considered for the two eyes together (irritation/burning/stinging, foreign body sensation, tearing, itching or dry eye sensation) of at least mild severity (grade ≥ 2) upon non-instillation OR One ocular symptom of at least mild severity (grade ≥ 2) upon non-instillation AND
Key exclusion criteria (12 listed)
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- Anterior chamber angle in either eye to be treated less than grade 2 according to Schaffer classification as measured by gonioscopy
- Any corneal abnormality or other condition preventing reliable applanation tonometry, including prior refractive eye surgery
- IOP greater than 22 mmHg at 15:00 IOP measurement in either eye at Screening/Baseline visit
- Use of preserved eye drops (other than latanoprost) including artificial tears at screening or within two weeks prior to screening visit
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 0.0015%Also: Taflotan®, Taflotan sine®, Saflutan®, Saflutan Conserveermiddelvrij®Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months. | Drug | Tafluprost 0.0015% |
Primary outcome
Change from screening in corneal confocal microscopic findings at month 12
Time frame: Baseline and Month 12
1 secondary outcome
Change from screening in ocular symptoms and signs upon non-instillation
Time frame: Baseline and Month 12
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 28 Oct 2014.
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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.
Hannu Uusitalo, MD, PhD principal investigator
Clinical Trial Center, FinnMedi Oy
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 0.0015% in people with Ocular Hypertension and Open-Angle Glaucoma, run by FinnMedi Oy at 1 site in Finland.
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 12 inclusion and 12 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 28 Oct 2014. 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 Finland. 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?
Change from screening in corneal confocal microscopic findings at month 12 (time frame: Baseline and Month 12). 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 28 Oct 2014.