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.
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 The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.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
50
Patients prescribe PG mono who occurs OSD or I IOP lower insufficient. patients switch to combination therapy.
Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
Taoyuan City, Taiwan
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
Time frame: 6 months post initiation
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
Time frame: 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
Time frame: 12 weeks post initiation
Evaluation of clinical signs with Tafluprost / Timolol
o Change in conjunctival hyperaemia distribution by severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post initiation
Physician assessment of patient compliance compared to previous therapy
* Better * Equal * Worse
Time frame: 6 months post initiation
Concomitant therapy for glaucoma
Record concomitant therapy from baseline to 6 months post initiation
Time frame: 6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol
o Change in corneal fluorescein staining (CFS) distribution by severity. Optional
Time frame: 6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol
o Mean change in Visual acuity (VA)
Time frame: 6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol
o Mean change in Schirmer's test. Optional
Time frame: 6 months post initiation
Evaluation of clinical signs with Tafluprost / Timolol
o Mean change in tear break up time (TBUT). Optional
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months post initiation
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