Study of how tafluprost 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.

• Register: EUCTR
• Last refreshed on: 17 July 2017
• Main ID: EUCTR2013-004302-26-SK
• Date of registration: 26/01/2016
• Prospective Registration: Yes
• Primary sponsor: Santen Oy
• Public title: Study of how tafluprost 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.
• Scientific 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. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.
• Date of first enrolment: 22/04/2016
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004302-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Hungary, Poland, Slovakia, United Kingdom, United States

Contacts

• Name: Sarah Johnstone
• Affiliation: INC Research

• Name: Sarah Johnstone
• Affiliation: INC Research

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient is a non-smoking male or female = 17 years of age on the day of signing the informed consent with the first day of study drug dosing to occur prior to the 18th birthday. Infants less than 12 months old must be of = 36 weeks gestational age and at least 1 month of age.
2. A diagnosis of primary or secondary paediatric glaucoma or ocular hypertension in one or both eyes.
3. A history of intraocular pressure (IOP) greater than or equal to 22 mmHg in at least one eye. Newly diagnosed patients may have this criterion fulfilled at the prestudy visit.
4. Patient is currently prescribed ocular hypotensive medication or patient is treatmentnaïve.
5. Female patients of reproductive potential must demonstrate a negative pregnancy test at the prestudy visit.
6. 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 .
7. Patient has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy visit.
8. Parent/legal guardian and/or patient have/has provided a written informed consent and patient assent has been given as applicable.
9. The patient and parent/guardian should agree to comply with study restrictions, treatment plan, procedures and keep scheduled clinic visits.
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1. Patient currently wears continuous wear contact lenses (use of daily wear contact lenses during the study is permitted).
2. Onesighted or monocular patients, including patients who cannot be dosed in both eyes for any reason.
3. History of goniotomy or trabeculotomy within 1 month of prestudy visit or history of cataract surgery, laser surgery, filtration surgery, implant surgery or cyclodestructive surgery within 3 months prior to prestudy visit in one or both eyes.
4. Patient has a history or evidence of significant ocular trauma within 3 months of prestudy visit.
5. Patient has a history or evidence of recent ocular inflammation and/or infection within 1 month of prestudy visit.
6. Patient has chronic conjunctivitis, chronic keratitis or lacrimal deficiency.
7. Patient is pregnant, breastfeeding, expecting to conceive within the projected duration of the study.
8. Patient has had major (nonocular) surgery, loss of > 5 cc/kg of blood within 4 weeks of the prestudy visit.
9. Any other ocular, systemic or psychiatric disease/condition or laboratory abnormality 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.
10. History of febrile illness within 5 days prior to start of study treatment.
11. 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).
12. Patient has a history of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription
(overthecounter) drugs or food.
13. There is any concern by the investigator regarding the safe participation of a patient in the study; or for any other reason the investigator considers the patient inappropriate for participation in the study.
14. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days from the prestudy visit.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Glaucoma or Ocular Hypertension
MedDRA version: 18.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Trade Name: Tafluprost
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: tafluprost
CAS Number: 209860-88-8
Current Sponsor code: TAFLUPROST
Other descriptive name: TAFLUPROST
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.015-

Primary Outcome(s)

Main Objective: The main objective of this study is to evaluate the pharmacokinetics (PK) of preservativefree tafluprost 0.0015% eye drops in paediatric patients of at least 36 week gestation and 1 month postnatal to under 18 years of age diagnosed with paediatric glaucoma or ocular hypertension (OHT).

Primary end point(s): Testing of tafluprost acid plasma concentrations that are drawn at Day 8 visit.

Secondary Objective: The secondary objective is to evaluate tolerability and safety of preservativefree tafluprost 0.0015% eye drops in pediatric patients of at least 36 week gestation and 1 month postnatal to under 18 years of age diagnosed with pediatric glaucoma or ocular hypertension (OHT).

Timepoint(s) of evaluation of this end point: Day 8: before the administration and then 10, 30 and 60 minutes after the administration of tafluprost eye drops.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: All visits (prestudy, day 1, day 8 and poststudy).

Secondary end point(s): Assessment of safety and tolerability at all visits. Will be followed with the following variables:
1. Adverse events
2. Bestcorrected visual acuity
3. Intraocular pressure
4. Biomicroscopy
5. Ophthalmoscopy
6. Vital signs: blood pressure and heart rate, respiratory rate, body temperature
7. ECG
8. Laboratory safety tests

Secondary ID(s)

2013-004302-26-GB

201350

Source(s) of Monetary Support

Santen Oy