Clinical trial NCT04828057: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Surface Disease
Primary Open Angle Glaucoma
Keywords: tafluprost
Tapcom-s
switching
Lead sponsor: Santen Pharmaceutical (Taiwan) Co., LTD
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population for the current study is all eligible patients who received at least one prescription of Tafluprost / Timolol in Taiwan; however, the sample population will be limited to eligible patients in the clinics included in the study

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change of intraocular pressure (IOP)
timeFrame: 6 months post initiation
Secondary outcomes:
measure: Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks
timeFrame: from baseline to after 4 and 12 weeks of treatment from initiation
measure: Proportion of responders at 12 weeks, defined as change from baseline IOP of 20% or more
timeFrame: 12 weeks post initiation
measure: Evaluation of clinical signs with Tafluprost / Timolol
timeFrame: 6 months post initiation
measure: Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.
timeFrame: 6 months post initiation
measure: Evaluation of the effectiveness (IOP-development) of Tafluprost / Timolol by the physician as measured by change in distribution by severity
timeFrame: 6 months post initiation
measure: Evaluation of clinical signs during therapy with Tafluprost / Timolol by the physician as measured by change in distribution by severity
timeFrame: 6 months post initiation
measure: Evaluation of tolerability of Tafluprost / Timolol by the Patient as measured by change in distribution by severity
timeFrame: 6 months post initiation
measure: Physician assessment of patient compliance compared to previous therapy
timeFrame: 6 months post initiation
measure: Concomitant therapy for glaucoma
timeFrame: 6 months post initiation
measure: Evaluation of clinical signs with Tafluprost / Timolol
timeFrame: 6 months post initiation
measure: Evaluation of clinical signs with Tafluprost / Timolol
timeFrame: 6 months post initiation
measure: Evaluation of clinical signs with Tafluprost / Timolol
timeFrame: 6 months post initiation
measure: Evaluation of clinical signs with Tafluprost / Timolol
timeFrame: 6 months post initiation
measure: Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.
timeFrame: 6 months post initiation
measure: Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.
timeFrame: 6 months post initiation
measure: Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.
timeFrame: 6 months post initiation
measure: Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.
timeFrame: 6 months post initiation
measure: Change in the evaluation of subjective symptoms with Tafluprost / Timolol. Difference in distribution by severity. Severity categorized as none, mild, moderate, severe.
timeFrame: 6 months post initiation
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
Study officials:
affiliation: Chang-Geng Medical Foundation Linkou Chang-Geng Memorial Hospital
name: Wei-wen Su
role: PRINCIPAL_INVESTIGATOR
References: