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

Primary Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828057
• Other study ID #: TW-VISIONARY Study
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: August 24, 2022

Study information

• Verified date: October 2022
• Source: Santen Pharmaceutical (Taiwan) Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Ocular Surface Disease
• Primary Open Angle Glaucoma

Intervention

Drug:
• Tafluprost, timolol maleate
Patients prescribe PG mono who occurs OSD or I IOP lower insufficient. patients switch to combination therapy.

Locations

Country	Name	City	State
Taiwan	Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital	Taoyuan city

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical (Taiwan) Co., LTD

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evaluation of clinical signs with Tafluprost / Timolol	o Change in conjunctival hyperaemia distribution by severity	6 months post initiation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Physician assessment of patient compliance compared to previous therapy	Better; Equal; Worse	6 months post initiation
Secondary	Concomitant therapy for glaucoma	Record concomitant therapy from baseline to 6 months post initiation	6 months post initiation
Secondary	Evaluation of clinical signs with Tafluprost / Timolol	o Change in corneal fluorescein staining (CFS) distribution by severity. Optional	6 months post initiation
Secondary	Evaluation of clinical signs with Tafluprost / Timolol	o Mean change in Visual acuity (VA)	6 months post initiation
Secondary	Evaluation of clinical signs with Tafluprost / Timolol	o Mean change in Schirmer's test. Optional	6 months post initiation
Secondary	Evaluation of clinical signs with Tafluprost / Timolol	o Mean change in tear break up time (TBUT). Optional	6 months post initiation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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