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

Santen

Status: Completed

Conditions: Primary Open Angle Glaucoma; Ocular Surface Disease

Treatments: Drug: Tafluprost, timolol maleate

Study type: Observational

Funder types: Industry

Identifiers

NCT04828057

TW-VISIONARY Study

Details and patient eligibility

About

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.

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 The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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