Status:
COMPLETED
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
Lead Sponsor:
Santen Pharmaceutical (Taiwan) Co., LTD
Conditions:
Ocular Surface Disease
Primary Open Angle Glaucoma
Eligibility:
All Genders
20+ years
Brief 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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 24 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04828057
Start Date
September 1 2021
End Date
August 24 2022
Last Update
October 31 2022
Active Locations (1)
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1
Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
Taoyuan, Taiwan, 333012