Preservative-free Tafluprost/Timolol Fixed Combination: Morning vs Evening Dosing
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional
Phase: Phase 4

Summary: 
      The ideal dosing for preservative-free tafluprost/timolol fixed combination remains to be
      elucidated. The present study compared the 24-hour intraocular pressure efficacy obtained
      with tafluprost/timolol given once in the evening with placebo once in the morning, versus
      that with the same fixed combination administered once in the morning with placebo given once
      in the evening in consecutive patients with open-angle glaucoma insufficiently controlled
      with branded, or generic latanoprost monotherapy.
    

Detailed description: 
      Prospective, observer-masked, placebo-controlled, crossover, comparison in consecutive
      open-angle glaucoma patients, insufficiently controlled with preserved latanoprost
      monotherapy (mean 24-hr IOP greater than 20 mmHg). Patients were randomized to either morning
      (08:00), or evening (20:00) preservative-free tafluprost/timolol fixed combination for 3
      months and then were crossed over. After each treatment period patients underwent habitual
      24-hour intraocular pressure monitoring with Goldmann tonometry in the sitting position (at
      10:00, 14:00, 18:00 and 22:00) and Perkins tonometry in the supine position (at 02:00 and
      06:00).

      Primary Study Objective: Mean 24-hour efficacy with both dosing regimens of
      tafluprost/timolol fixed combination versus latanoprost monotherapy.

      Secondary Study Objectives

        1. Mean efficacy with the evening dosing of tafluprost/timolol compared with the
           morning-dosed tafluprost/timolol fixed combination at each time point measured.

        2. Mean daytime and mean nighttime IOP control with the two dosing regimens.

        3. Mean peak and fluctuation of 24-hour pressure with the evening and the morning dosing of
           the fixed combination.
    

Intervention name(s): Tafluprost/timolol fixed combination
Intervention type(s): Drug
Intervention description(s): Evaluation of 24-hour pressure control with tafluprost/timolol given in the evening or morning
Other intervention name(s): Taptiqom
Intervention MeSH terms: Timolol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients first undergo a baseline, habitual 24-hour pressure assessment with branded, or generic latanoprost. Suitably qualified open-angle glaucoma patients (latanoprost-treated, mean 24-hour pressure greater than 20 mm Hg) are randomized for Period 1 to receive either tafluprost/timolol fixed combination drops once in the evening (20:00) and placebo drops in the morning (08:00), or tafluporst/timolol drops once in the morning (08:00) and placebo in the evening (20:00). After 3 months of chronic therapy (± 2 weeks) study patients undergo a treated, habitual 24-hour pressure assessment. Study subjects are then switched to the opposite treatment regimen for Period 2 (tafluprost/timolol in the evening instead of morning etc) and after another 3 months they undergo the third and final evaluation of their 24-hour pressure.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: tafluprost/timolol fixed combination, 24-hour IOP control