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

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Ocular Surface Disease
• Intervention / Treatment: Drug: Tafluprost, timolol maleate

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 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 not continued after the first prescription. In addition, patients must have their IOP recorded within 7 days before their first prescription of Tafluprost / Timolol, in order to be eligible for this study. Only those who provide informed consent will be included.

At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the patient is included in the study and relevant data will be recorded during routine clinical visits. Participation in this study is entirely voluntary; any patient may withdraw consent to participate in this study at any time. The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan city, Taiwan, 333012
    • Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The target population for the current study is all eligible patients who received at least one prescription of Tafluprost / Timolol in Taiwan; however, the sample population will be limited to eligible patients in the clinics included in the study

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of intraocular pressure (IOP)	The primary endpoint will be assessed for the whole patient group and separately in specific subgroups according to their last glaucoma treatments before initiating Tafluprost / Timolol. Classification of prior therapy	6 months post initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks	Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks of treatment from initiation	from baseline to after 4 and 12 weeks of treatment from initiation
Proportion of responders at 12 weeks, defined as change from baseline IOP of 20% or more	Proportion of responders at 12 weeks,defined as change from baseline IOP of 20% or more	12 weeks post initiation
Evaluation of clinical signs with Tafluprost / Timolol	o Change in conjunctival hyperaemia distribution by severity	6 months post initiation
Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.	o Dry eye	6 months post initiation
Evaluation of the effectiveness (IOP-development) of Tafluprost / Timolol by the physician as measured by change in distribution by severity	Better than prior medication; Same as prior medication; Worse than prior medication	6 months post initiation
Evaluation of clinical signs during therapy with Tafluprost / Timolol by the physician as measured by change in distribution by severity	Better than prior medication; Same as prior medication; Worse than prior medication	6 months post initiation
Evaluation of tolerability of Tafluprost / Timolol by the Patient as measured by change in distribution by severity	Very good; Good; Satisfactorily; Poor	6 months post initiation
Physician assessment of patient compliance compared to previous therapy	Better; Equal; Worse	6 months post initiation
Concomitant therapy for glaucoma	Record concomitant therapy from baseline to 6 months post initiation	6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol	o Change in corneal fluorescein staining (CFS) distribution by severity. Optional	6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol	o Mean change in Visual acuity (VA)	6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol	o Mean change in Schirmer's test. Optional	6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol	o Mean change in tear break up time (TBUT). Optional	6 months post initiation
Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.	o Irritation	6 months post initiation
Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.	o Itching eyes	6 months post initiation
Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.	o Foreign body sensation	6 months post initiation
Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.	o Eye pain	6 months post initiation
Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.	o Other	6 months post initiation

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical (Taiwan) Co., LTD
• Investigators: Principal Investigator: Wei-wen Su, Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): August 24, 2022
• Study Completion (ACTUAL): August 24, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: switching; tafluprost; Tapcom-s
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Travoprost; Bimatoprost; Latanoprost
• Other Study ID Numbers: TW-VISIONARY Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No