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 (Taptiqom)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other

  Safety study (incl. comparative)
• If ‘other’, further details on the scope of the study:
  Tolerability and safety in a real world setting
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, non-interventional study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TAFLUPROST

  TIMOLOL
• Medical condition to be studied:
  Glaucoma

Population studied

• Short description of the study population:
  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 The withdrawn patient’s data will not be analysed in this study and the number of patients who withdrew consent will appear in the final study report.; Inclusion criteria; •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; o Male or female patients ≥18 years of age at time of informed consent o Diagnosis of open angle glaucoma or ocular hypertension; o Insufficient IOP control with a monotherapy utilising topical beta blockers or prostaglandin analogues, necessitating the use of a combination therapy according to the judgement of the treating ophthalmologist; o Patient judged by their physician to benefit from preservative free eye drops; 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 st
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Ocular hypertension patients
• Estimated number of subjects:
  650

Study design details

• Main study objective:
  The primary objective of this non-interventional study with Tafluprost / Timolol is to evaluate the effectiveness of Tafluprost / Timolol in routine clinical practice, as measured by the mean change in intraocular pressure 6 months post initiation of Tafluprost / Timolol therapy, in patients with open angle glaucoma or ocular hypertension.
• Outcomes:
  The primary endpoint will also be estimated as a baseline adjusted change using a normal linear regression model. In this model, change from baseline in IOP will be modelled as a function of the baseline value and relevant covariates. Mean change in intra-ocular pressure (IOP) from baseline to after 4 and 12 weeks of treatment from initiation (± 7 days)Proportion of responders at 12 weeks, defined as change from baseline IOP of 20% or moreAssessing the effectiveness of Tafluprost / Timolol in reducing clinical signs and subjective symptoms after 6 months of treatment in routine clinical practiceAssess the tolerabi
• Data analysis plan:
  Primary dataset/full analysis set (FAS): all patients having signed informed consent form and prescribed Tafluprost / Timolol (TT) at least once, irrespective of whether patients continued TT after first prescription.Secondary effectiveness analysis set (EAS): all patients in the FAS having continued Tafluprost/Timolol treatment for 6 months after initiation, with at least one measurement of intraocular pressure (IOP) at 6 months (± 45 days) after initiation. The primary analysis will compare IOP value at baseline and at 6 months after TT treatment start. The primary endpoint will also be estimated as a baseline adjusted change using a normal linear regression model. IOP change from baseline will be modelled as a function of the baseline value and relevant covariates. Results will be presented overall and by previous treatment and country.Secondary endpoints will be presented descriptively.

Documents

Study, other information

Glaucoma_All_site

sites final 0240-0024