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
Verified date | October 2022 |
Source | Santen Pharmaceutical (Taiwan) Co., LTD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital | Taoyuan city |
Lead Sponsor | Collaborator |
---|---|
Santen Pharmaceutical (Taiwan) Co., LTD |
Taiwan,
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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