LONG-TERM SURVEILLANCE STUDY OF LATANOPROST TO MONITOR HYPERPIGMENTATION CHANGES IN THE EYE IN PEDIATRIC POPULATIONS

Study identification

• EU PAS number:
  EUPAS6023
• Study ID:
  38741
• Official title and acronym:
  LONG-TERM SURVEILLANCE STUDY OF LATANOPROST TO MONITOR HYPERPIGMENTATION CHANGES IN THE EYE IN PEDIATRIC POPULATIONS
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Colombia

  Denmark

  France

  Germany

  Greece

  Italy

  Peru

  Portugal

  Slovakia

  Spain

  Sweden

  United Kingdom
• Study description:
  This study is one of the two post-authorization safety studies (PASS) that have been designed to monitor hyperpigmentation changes in the eye for 10 years in pediatric patients treated with latanoprost. The first study is an ongoing cohort study with 3-year follow-up (A6111143) to evaluate the long‑term safety profile (including, but not limited to hyperpigmentation changes in the eye) of latanoprost use in pediatric populations. This long‑term surveillance study (A6111144) will be initiated by inviting all patients completing the 3‑year follow up of the A6111143 study to participate, and hyperpigmentation changes in the eye will be monitored over the subsequent 7‑year period. The objective of the A6111144 study is to describe the incidence of hyperpigmentation changes in the eye over a total of 10 years of follow up by combining data collected from the 3-year follow-up in the A6111143 study and the extended 7-year follow-up in the A6111144 study, among pediatric patients with glaucoma or elevated intraocular pressure (IOP). Patients enrolled in the A6111144 study will be classified into the latanoprost exposed, topical prostaglandin analogue (PGA) unexposed, and non latanoprost topical PGA exposed groups. Patients’ exposure status, hyperpigmentation change in the eye, basic clinical characteristics (i.e. visual acuity, IOP, optic nerve structure, visual field) will be obtained at the end of each year for 7 years. Concomitant medications and adverse events will be recorded throughout the study period. Incidence proportions and incidence rates of hyperpigmentation changes in the eye will be calculated for the entire 10 year follow-up period. FSFV of this study is estimated to occur in January 2014 (± 2 months) and LSLV is estimated to occur in January 2023 (± 2 months). Submission of the final study report will occur within one year after the LSLV (estimated January 2024 ± 2 months).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Parexel International

United States

Study timelines

Date when funding contract was signed

Planned: 28/02/2014

Actual: 28/02/2014

Study start date

Planned: 11/03/2014

Actual: 11/03/2014

Data analysis start date

Planned: 01/02/2023

Actual: 08/05/2023

Date of interim report, if expected

Planned: 31/07/2019

Actual: 03/07/2019

Date of final study report

Planned: 31/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Viatris Specialty LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)