Ocular HypertensionPhase 3NCT01292460
Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against Monotherapies
A Phase 3 study of Ocular Hypertension and Open-angle Glaucoma, run by Santen Oy at 2 sites in Finland.
Trial summary
The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open-angle Glaucoma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesFinland
- Study dates
- Feb 2011to Sep 2012
- Phase
- Phase 3
- 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
- Aged 18 years or more
- A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or prostaglandin.
- Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (baseline).
- Meet specific visual acuity score
- Are willing to follow instructions
- Have provided a written informed consent
Who cannot join
- Females who are pregnant, nursing or planning pregnancy
- IOP of 35 mmHg or greater
- Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
- Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse)or to wash-out medication brinzolamide
- Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
- Use of contact lenses at Screening or during the study
- Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters
- Current participation in another clinical trial within the last 30 days
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Eye clinic, University Hospital of Kuopio
Kuopio, 70210
Eye Clinic, University Hospital of Oulu
Oulu, 90029 OYS
About this study
Official title: A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension
The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.
The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.
- Conditions
- Ocular Hypertension, Open-angle Glaucoma
- Being tested
- Timolol/ FDC/ Placebo/ Tafluprost
- 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.
Timolol/ FDC/ Placebo/ TafluprostDrug
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
| Study group | Role | What they receive |
|---|---|---|
| Preservative-free timolol | Active comparator | Not described Receives: Drug: Timolol/ FDC/ Placebo/ Tafluprost |
| Preservative-free FDC and placebo | Experimental | Not described Receives: Drug: Timolol/ FDC/ Placebo/ Tafluprost |
| Preservative-free tafluprost | Active comparator | Not described Receives: Drug: Timolol/ FDC/ Placebo/ Tafluprost |
| Preservative-free FDC | Experimental | Not described Receives: Drug: Timolol/ FDC/ Placebo/ Tafluprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
Measured: At 3 months
Secondary outcomes (2)
Change from baseline in average diurnal IOP
Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months
Measured: At 2 and 6 weeks and 6 months
Change from baseline in timewise IOPs
Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)
Measured: At 2 weeks, 6 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Auli Ropo, M.D., Study director, Santen OyHannu Uusitalo, M.D., Prof., Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292460
- Sponsor's protocol ID
- 201050
- Status last verified
- Mar 2011
- First submitted
- 8 Feb 2011
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.
PubMed 25447269
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those Given Individually in Patients With Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01292460
- Acronym / sponsor ID
- 201050
- Conditions
- Ocular Hypertension, Open-angle Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Santen OyIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 9 Feb 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 purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.
The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preservative-free timolol | Active comparator | Drug: Timolol/ FDC/ Placebo/ Tafluprost |
| Preservative-free FDC and placebo | Experimental | Drug: Timolol/ FDC/ Placebo/ Tafluprost |
| Preservative-free tafluprost | Active comparator | Drug: Timolol/ FDC/ Placebo/ Tafluprost |
| Preservative-free FDC | Experimental | Drug: Timolol/ FDC/ Placebo/ Tafluprost |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or more
- A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or prostaglandin.
- Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (baseline).
- Meet specific visual acuity score
- Are willing to follow instructions
Key exclusion criteria (8 listed)
- Females who are pregnant, nursing or planning pregnancy
- IOP of 35 mmHg or greater
- Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
- Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse)or to wash-out medication brinzolamide
- Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
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 |
|---|---|---|
| Timolol/ FDC/ Placebo/ TafluprostPrior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00). | Drug | Preservative-free FDC, Preservative-free FDC and placebo, Preservative-free tafluprost, Preservative-free timolol |
Primary outcome
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
Time frame: At 3 months
2 secondary outcomes
Change from baseline in average diurnal IOP
Time frame: At 2 and 6 weeks and 6 months
Change from baseline in timewise IOPs
Time frame: At 2 weeks, 6 weeks, 3 months and 6 months
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 13 Mar 2013.
- Derived from this study: PubMed 25447269Pfeiffer N, Traverso CE, Lorenz K, Saarela V, Liinamaa J, Uusitalo H, Astakhov Y, Boiko E, Ropo A; Preservative-free Tafluprost/Timolol Fixed Combination Study Group. A 6-month study comparing efficacy, safety, and tolerability of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% versus each of its individual preservative-free components. Adv Ther. 2014 Dec;31(12):1228-46. doi: 10.1007/s12325-014-0163-3. Epub 2014 Dec 2.
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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.
Auli Ropo, M.D. study director
Santen Oy
Hannu Uusitalo, M.D., Prof. principal investigator
Tampere University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Ocular Hypertension and Open-angle Glaucoma, run by Santen Oy at 2 sites 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 6 inclusion and 8 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 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 baseline in the average diurnal Intraocular Pressure (IOP) at 3 months (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01292460, which also lists 1 linked publication.
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 13 Mar 2013.