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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.

Official Title
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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

Conditions
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Ocular Surface Disease, Primary Open Angle Glaucoma

Intervention / Treatment
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* Drug: Tafluprost, timolol maleate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tafluprost, Tapcom-s, switching