Healthy VolunteersPhase 1NCT01434888
Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
A Phase 1 study testing Preservative free tafluprost 0.0015% eye drops, Preservative free timolol 0.5% eye drops and Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops in people with Healthy Volunteers, run by Santen Oy at 1 site in Finland.
Trial summary
The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Preservative free tafluprost 0.0015% eye drops, Preservative free timolol 0.5% eye drops and Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2011to Dec 2011
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 45 years
- Good general health
- Meet best corrected ETDRS visual acuity
Who cannot join
- Significant systemic or ocular disease
- History of eye surgery, including refractive surgery
- Allergy or hypersensitivity to study drug
- Low heart rate (<50 bpm)
- Clinically relevant low blood pressure
- Asthma
Show all 11Show fewer
- Bradycardia
- Use of contact lenses within one week prior to screening or during the study
- Clinically significant obesity (body mass index > 30 kg/m2)
- Blood donation within 2 months prior to screening
- Females who are pregnant or lactating and females not using adequate contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-masked, 3-period Cross-over Clinical Study to Compare the Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops to Those of Preservative-free Tafluprost 0.0015% and Timolol 0.5% Eye Drops in Healthy Volunteers
The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Preservative free tafluprost 0.0015% eye drops, Preservative free timolol 0.5% eye drops, Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops
- Keywords
- pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative free tafluprost 0.0015% eye dropsDrug
Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.
Preservative free timolol 0.5% eye dropsDrug
Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days
Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye dropsDrug
Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.
| Study group | Role | What they receive |
|---|---|---|
| Tafluprost 0.0015% | Active comparator | Not described Receives: Drug: Preservative free tafluprost 0.0015% eye drops |
| Timolol 0.5% | Active comparator | Not described Receives: Drug: Preservative free timolol 0.5% eye drops |
| Fixed-dose combination of tafluprost 0.0015% and timolol 0.5% | Experimental | Not described Receives: Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.
Measured: There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7
Secondary outcomes (1)
Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
The changes from screening/baseline will be evaluated in following variables:visual acuity, IOP, biomicroscopy and ophthalmoscopy findings and drop discomfort.
Adverse events will be followed from screening to post-study visit.
Measured: Day 1 and Day 7 of treatment periods I, II and III.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434888
- Sponsor's protocol ID
- 201150
- Other IDs
- 2011-001778-24
- Status last verified
- Jun 2012
- First submitted
- 12 Sep 2011
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-masked, 3-period Cross-over Clinical Study to Compare the Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops to Those of Preservative-free Tafluprost 0.0015% and Timolol 0.5% Eye Drops in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01434888
- Acronym / sponsor ID
- 201150
- Conditions
- Healthy Volunteers
- Keywords
- pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Santen OyIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Sep 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 the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tafluprost 0.0015% | Active comparator | Drug: Preservative free tafluprost 0.0015% eye drops |
| Timolol 0.5% | Active comparator | Drug: Preservative free timolol 0.5% eye drops |
| Fixed-dose combination of tafluprost 0.0015% and timolol 0.5% | Experimental | Drug: Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 45 years
- Good general health
- Meet best corrected ETDRS visual acuity
Key exclusion criteria (11 listed)
- Significant systemic or ocular disease
- History of eye surgery, including refractive surgery
- Allergy or hypersensitivity to study drug
- Low heart rate (<50 bpm)
- Clinically relevant low blood pressure
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 tafluprost 0.0015% eye dropsPreservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00. | Drug | Tafluprost 0.0015% |
| Preservative free timolol 0.5% eye dropsPreservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days | Drug | Timolol 0.5% |
| Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye dropsPreservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00. | Drug | Fixed-dose combination of tafluprost 0.0015% and timolol 0.5% |
Primary outcome
Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Time frame: There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7
The primary evaluation of pharmacokinetics will be based on the plasma concentration of tafluprost acid and timolol.
1 secondary outcome
Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
Time frame: Day 1 and Day 7 of treatment periods I, II and III.
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 8 Jun 2012.
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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 1 study testing Preservative free tafluprost 0.0015% eye drops, Preservative free timolol 0.5% eye drops and Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops in people with Healthy Volunteers, run by Santen 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 3 inclusion and 11 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 8 Jun 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops. (time frame: There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7). 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 8 Jun 2012.