Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients.
Research type
Research Study
Full title
A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in paediatric patients diagnosed with glaucoma or ocular hypertension.
IRAS ID
152721
Contact name
Annegret Dahlmann-Noor
Contact email
Sponsor organisation
Santen Oy
Eudract number
2013-004302-26
Research summary
This is a paediatric medical research study evaluating pharmacokinetics (PK), safety and tolerability of the study drug; preservative free tafluprost ophthalmic solution (0.0015%) (Eye drops), being tested in patients diagnosed with paediatric glaucoma or ocular hypertension (OHT).
Paediatric glaucoma also known as childhood glaucoma is a rare condition that occurs in babies and young children. It is usually diagnosed within the first year of life. This condition causes increased intraocular pressure (IOP) increasing the risk of optic nerve damage and loss of visual field in the eye. Symptoms include enlarged, eyes, opaque cornea and sensitivity to light.
Paediatric patients with OHT have an intraocular pressure that is higher than normal but with no optic nerve damage or visual field loss.
Tafluprost 0.0015% eye drops is currently approved to treat open angle glaucoma (OAG) and ocular hypertension (OHT) in adult patients.
About eighteen male and female paediatric patients with glaucoma or ocular hypertension; aged at least 36 week gestation and 1 month post-natal to those aged under 18 years of age will be recruited for this study:
Approximately 6 subjects from 2 or 3 study sites are expected in the United Kingdom and 12 subjects from 4 or 5 study sites are anticipated for the United States.
The duration of the treatment period with the study medication will be 7-9 Days.
Participants can expect to be in study for about 1month depending on the study visit schedule i.e. washout period prior to treatment (assessed by Investigator).
The treatment period is followed by a post-study visit/contact in 1-3 weeks after Day 8 visit.
A patient information sheet describing the study will be provided.
Parent/guardian consent for participation will be required for child participants who are under the age of 16 years.
Participation in this study is entirely voluntary.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/1065
Date of REC Opinion
5 Sep 2014
REC opinion
Further Information Favourable Opinion