GlaucomaPhase 1NCT02102750
A Study to Evaluate Pharmacokinetics of Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients With Glaucoma or Ocular Hypertension
A Phase 1 study testing Preservative free tafluprost opthalmic solution in people with Glaucoma and Ocular Hypertension, run by Santen Oy at 2 sites in 2 countries.
Trial summary
The purpose of the study is to examine how preservative free tafluprost ophthalmic solution (0.0015%) is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Preservative free tafluprost opthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2014to 3 Jul 2017
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is a non-smoking male or female ≤ 17 years of age on the day of signing the informed consent. Infants must be at least 1 month of age
- A diagnosis of primary or secondary pediatric glaucoma or ocular hypertension in one or both eyes
- A history of IOP greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the pre-study visit.
- Patient is currently prescribed ocular hypotensive medication and who according to investigator's judgement may discontinue the use at least day before the Day 1 visit, or patient is treatment-naïve (those who have never used used ocular hypotensive medication).
- Female patients of reproductive potential must demonstrate a negative pregnancy test at the pre-study visit
- Patient is judged to be in good health, other than having glaucoma or ocular hypertension, based on medical history, physical examination, vital signs measurements, and laboratory safety tests performed at the pre-study visit and/or prior to administration of the initial dose of study drug
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- Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the pre-study visit
- Parent/legal guardian and/or patient have/has provided a written informed consent (according to existing local regulations) and patient assent has been given as applicable.
- The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep scheduled clinic visits.
Who cannot join
- Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted)
- One-sighted or monocular patients, including patients who cannot be dosed in both eyes for any reason
- History of goniotomy or trabeculotomy within 1 month of pre-study visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive surgery within 3 months prior to pre-study visit in one or both eyes.
- Patient has a history or evidence of significant ocular trauma within 3 months of prestudy visit
- Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of pre-study visit
- Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency
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- Patient is pregnant, breastfeeding, expecting to conceive within the projected duration of the study
- Patient has had major (non-ocular) surgery, loss of > 5 cc/kg of blood within 4 weeks of the pre-study visit
- Any other ocular, systemic or psychiatric disease/condition or laboratory abnormality
- History of febrile illness within 5 days prior to start of study treatment
- Patient has a history of hypersensitivity to any component of tafluprost eye drops, or known severe or serious hypersensitivity to any prostaglandin analogue product (e.g. latanoprost)
- Patient has a history of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription (over-the-counter) drugs or food
- There is any concern by the investigator regarding the safe participation of a patient in the study
- Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days from the pre-study visit
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Childrens Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Preservative Free Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients Diagnosed With Glaucoma or Ocular Hypertension
The purpose of the study is to examine how preservative free tafluprost ophthalmic solution (0.0015%) is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Preservative free tafluprost opthalmic solution
- 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 tafluprost opthalmic solutionDrug
0.0015% eye drops q.d, in both eyes for 7 to 9 days
| Study group | Role | What they receive |
|---|---|---|
| tafluprost | Experimental | Not described Receives: Drug: Preservative free tafluprost opthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of tafluprost acid.
Measured: 8 days +/- 1 day window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJun 2014
- Primary completion29 May 2017
- Study completion3 Jul 2017
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Auli Ropo, Study director, Santen Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102750
- Sponsor's protocol ID
- 201350
- Other IDs
- 2013-004302-26
- Status last verified
- Oct 2017
- First submitted
- 31 Mar 2014
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Preservative Free Tafluprost Ophthalmic Solution (0.0015%) in Pediatric Patients Diagnosed With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT02102750
- Acronym / sponsor ID
- 201350
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Santen OyIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- 29 May 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 3 Apr 2014 (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 the study is to examine how preservative free tafluprost ophthalmic solution (0.0015%) is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tafluprost | Experimental | Drug: Preservative free tafluprost opthalmic solution |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patient is a non-smoking male or female ≤ 17 years of age on the day of signing the informed consent. Infants must be at least 1 month of age
- A diagnosis of primary or secondary pediatric glaucoma or ocular hypertension in one or both eyes
- A history of IOP greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the pre-study visit.
- Patient is currently prescribed ocular hypotensive medication and who according to investigator's judgement may discontinue the use at least day before the Day 1 visit, or patient is treatment-naïve (those who have never used used ocular hypotensive medication).
- Female patients of reproductive potential must demonstrate a negative pregnancy test at the pre-study visit
Key exclusion criteria (14 listed)
- Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted)
- One-sighted or monocular patients, including patients who cannot be dosed in both eyes for any reason
- History of goniotomy or trabeculotomy within 1 month of pre-study visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive surgery within 3 months prior to pre-study visit in one or both eyes.
- Patient has a history or evidence of significant ocular trauma within 3 months of prestudy visit
- Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of pre-study 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 |
|---|---|---|
| Preservative free tafluprost opthalmic solution0.0015% eye drops q.d, in both eyes for 7 to 9 days | Drug | tafluprost |
Primary outcome
Plasma concentration of tafluprost acid.
Time frame: 8 days +/- 1 day window
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 10 Oct 2017.
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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 study director
Santen Oy
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Preservative free tafluprost opthalmic solution in people with Glaucoma and Ocular Hypertension, run by Santen Oy at 2 sites in 2 countries.
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 9 inclusion and 14 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 10 Oct 2017. 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 United States, United Kingdom. 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?
Plasma concentration of tafluprost acid. (time frame: 8 days +/- 1 day window). 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 10 Oct 2017.