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Search / Trial NCT04828057

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

Launched by SANTEN PHARMACEUTICAL (TAIWAN) CO., LTD · Mar 30, 2021

Trial Information

Current as of May 06, 2025

Completed

Keywords

Tafluprost Tapcom S Switching

ClinConnect Summary

The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by mean change in intra-ocular pressure (IOP) from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT), who do not respond sufficiently to initial topical treatment, in routine clinical practice.

This study will include adults with open angle glaucoma or ocular hypertension, who received their first Tafluprost / Timolol prescription at baseline, even if Tafluprost / Timolol was...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
  • According to the approved indications of Tafluprost / Timolol as indicated in the SPC
  • Male or female patients ≥20 years of age at time of informed consent
  • Diagnosis of open angle glaucoma or ocular hypertension
  • Insufficient IOP control with a monotherapy utilizing topical prostaglandin analogues, necessitating the use of a combination therapy according to the judgement of the treating ophthalmologist
  • Patient judged by their physician to benefit from preservative free eye drops
  • Not used Tafluprost / Timolol before
  • Exclusion Criteria:
  • Patient pregnant or nursing
  • Pregnancy planned in the following 6 months
  • Presence of contraindications as listed in the SPC
  • Any ophthalmologic surgery within 6 months prior to the study
  • Participation in any other investigational study within 30 days prior to enrolment

About Santen Pharmaceutical (Taiwan) Co., Ltd

Santen Pharmaceutical (Taiwan) Co., Ltd. is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies for ophthalmic conditions. As a subsidiary of Santen Pharmaceutical Co., Ltd., headquartered in Japan, the company leverages advanced science and clinical expertise to address unmet medical needs in eye care. With a strong commitment to improving patient outcomes, Santen Pharmaceutical (Taiwan) actively participates in clinical trials and collaborates with healthcare professionals to enhance the quality of life for individuals suffering from eye diseases. Through its focus on innovation and patient-centric approaches, Santen aims to be at the forefront of ophthalmology in Taiwan and beyond.

Locations

Taoyuan City, , Taiwan

Patients applied

0 patients applied

Trial Officials

Wei-wen Su

Principal Investigator

Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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