A population-based cohort study using an existing database to evaluate the association between latanoprost use and primary malignant ocular melanoma and facial cutaneous melanoma

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15377
• EU PAS number:
  EUPAS8241
• Study ID:
  15377
• Official title and acronym:
  A population-based cohort study using an existing database to evaluate the association between latanoprost use and primary malignant ocular melanoma and facial cutaneous melanoma
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  The primary research aim of this study is to examine the potential association between latanoprost and primary malignant ocular melanoma (OM) and facial cutaneous melanoma (CM), respectively. The secondary research aim is to examine the potential association between prostaglandin analogues (PGAs) and primary malignant OM and facial CM, respectively. A population-based cohort study will be conducted based on secondary use of existing data. The study population will include patients with recorded glaucoma or ocular hypertension (OH) in the Swedish national health care registers from July 1st, 2005 to December 31st, 2011 and with no previous malignant melanoma. Exposure groups (latanoprost, other topical PGAs and topical non-PGAs) will be categorized based on drug exposure data collected from the Swedish Prescription Drug Register (SPDR). Primary malignant OM and facial CM of each patient will be identified from the Swedish Cancer Register (SCR). Cox regression models will be developed to evaluate independent effects of having OM and facial CM, respectively, in association with use of latanoprost and topical PGAs, adjusting for potential confounding variables.
• Study status:
  Finalised

Research institution and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Planned: 15/05/2013

Actual: 10/06/2013

Study start date

Planned: 15/02/2015

Actual: 05/01/2015

Data analysis start date

Planned: 15/04/2015

Actual: 12/05/2015

Date of final study report

Planned: 30/09/2016

Actual: 09/09/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.

Study protocol

Initial protocol

A6111157 Protocol_FINAL_15SEP2013_ENCePP

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)