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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04828057
Other study ID # TW-VISIONARY Study
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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 The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.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

Study Design


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
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