Preservative-free fixed-dose combination of tafluprost 0.0015% / timolol 0.5% in patients with open-angle glaucoma or ocular hypertension: Clinical effectiveness, tolerability and safety in a real world setting (Taptiqom)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36175
• EU PAS number:
  EUPAS22204
• Study ID:
  36175
• Official title and acronym:
  Preservative-free fixed-dose combination of tafluprost 0.0015% / timolol 0.5% in patients with open-angle glaucoma or ocular hypertension: Clinical effectiveness, tolerability and safety in a real world setting (Taptiqom)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  Hungary

  Ireland

  Italy

  Latvia

  Netherlands

  Norway

  Russian Federation

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a prospective, non-interventional study of the efficacy, tolerability and safety of Tafluprost / Timolol in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and require a combination therapy, and who would benefit from preservative free eye drops.
• Study status:
  Finalised

Research institutions and networks

Institutions

Irccs Fondazione G. B. Bietti

LKH - Universitaetsklinikum Graz austria, Rigshospitalet denmark, Bacs-Kiskun Megyei Korhaz hungary, Markusovszky Egyetemi Oktatokarhaz hungary, University of Debrecen hungary, PTE - Szemeszeti Klinika hungary, Bugat Pal Korhaz, Gyongyos hungary, Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont hungary, Szent Imre Kórház és Rendel¿intézet Szemészeti Osztály hungary, Semmelwis Egyetem SzemEszeti Klinika hungary

Study timelines

Date when funding contract was signed

Planned: 01/09/2016

Actual: 01/09/2016

Study start date

Planned: 10/04/2017

Actual: 10/04/2017

Data analysis start date

Planned: 07/10/2018

Date of final study report

Planned: 22/01/2019

Actual: 05/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

SANTEN

Study protocol

Initial protocol

Taptiqom_Santen_PhIV_Protocol v2.0

Updated protocol

Amended Protocol V5 13Feb2018_ clean_ Eng_Final (review 14feb18)_signed

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable