A6111144:Long Term Safety Study of Xalatan in Paediatric Populations
Research type
Research Study
Full title
A6111144: Long Term Surveillance study of Latanoprost to monitor hyperpigmentation changes in the eye in pediatric populations
IRAS ID
146623
Contact name
Peng T Khaw
Contact email
Sponsor organisation
Upjohn US 1 LLC
Duration of Study in the UK
8 years, 5 months, 1 days
Research summary
Glaucoma is a term that describes a group of eye conditions that affect vision. Latanoprost is a drug that has been approved for the treatment of glaucoma (open angle type) and when the pressure within the eye(s) is consistently elevated (ocular hypertension). Exposure to Latanoprost may gradually increase the amount of brown pigment in the eyes and may also affect the patient’s eyelashes, by increasing their length, thickness, number of eyelashes and occasionally the direction of the eyelashes grow. In addition there may also be darkening around the skin of the eye. These changes in the eye and eyelashes are called hyperpigmentation.
There is a regulatory requirement to provide more safety data regarding the children treated in a real world setting. The A611143 study was conducted to monitor the long term safety profile (including, but not limited to, hyperpigmentation changes in the eye)in paediatric patients for 3 years. After completion of the A6111143 study patients will be invited to participate in the A6111144 study which monitors for any hyperpigmentation changes in the eye for a further 7 years. A combination of the 3-year and 7-year studies allows the monitoring of any hyperpigmentation changes in the eye for a total of 10 years.
The A6111144 study is a non-interventional study (also known as an observational study) which means that Latanoprost will be prescribed to a patient by their doctor as part of normal medical practice and any assessments performed in the study will be part of the patient’s standard of care. The drug exposure status, any changes in hyperpigmentation around and/or in the eye and other important clinical characteristics will be assessed at the end of each year the participant is on the study, and adverse events will be monitored throughout the entire period.
REC name
London - Bromley Research Ethics Committee
REC reference
14/LO/0654
Date of REC Opinion
11 Apr 2014
REC opinion
Favourable Opinion