June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Preservative-free tafluprost 0.0015%/timolol 0.5% fixed dose combination: a 6-month double-masked, randomized multicenter P-III comparison to concomitant use of the individual preservative-free components in patients with glaucoma or ocular hypertension
Author Affiliations & Notes
  • Gabor Hollo
    Ophthalmology, Drosera BT, Solymar, Hungary
  • Anton Hommer
    Ophthalmolgy, Sanatorium Hera, Vienna, Austria
  • Alfonso Anton
    Institut Catala de Retina - Inici, Barcelona, Spain
  • Auli Ropo
    Clinical Research & Medical Affairs, Santen Oy, Helsinki, Finland
  • Footnotes
    Commercial Relationships Gabor Hollo, Alcon, Optovue (F), Alcon, MSD, Santen, NiCox, Pfizer, Optovue (C), Alcon, MSD, Santen, Pfizer, Zeiss (R), Alcon, MSD, Santen (S); Anton Hommer, Allergan (R), Allergan (C), Alcon (R), Santen (R), Merck (R); Alfonso Anton, ALCON (F), SANTEN (C), MSD (C), THEA (C), TRANSCEND (C), ALCON (R), ALLERGAN (R), SANTEN (R); Auli Ropo, Santen Oy (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 446. doi:
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      Gabor Hollo, Anton Hommer, Alfonso Anton, Auli Ropo; Preservative-free tafluprost 0.0015%/timolol 0.5% fixed dose combination: a 6-month double-masked, randomized multicenter P-III comparison to concomitant use of the individual preservative-free components in patients with glaucoma or ocular hypertension. Invest. Ophthalmol. Vis. Sci. 2013;54(15):446.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To evaluate the efficacy, tolerability and safety of preservative-free fixed dose combination (FDC) of tafluprost 0.0015% and timolol 0.5% once daily compared to the concomitant use of preservative-free tafluprost 0.0015% once daily and preservative-free timolol 0.5% twice daily (non-fixed combination, NFC).

Methods: This study was a 6-month double-masked randomised, multicenter parallel group investigation (clinicaltrial.gov No: NCT 01306461). After washout patients were randomised to either, preservative-free FDC tafluprost-timolol (once-daily) and placebo (twice daily) (n=201) or NFC of tafluprost (once-daily) and timolol (twice-daily) (n=199). Study visits included screening, baseline, 2, 6 weeks, 3 and 6 months. IOP was measured at 8 a.m., 10 a.m. and 4 p.m. during each visit. Primary efficacy variable was the change from average diurnal baseline IOP at month 6, secondary efficacy variable was the proportion of responders at month 6.

Results: A substantial and comparable IOP reduction from mean baseline IOP of 25.11 mmHg (identical for FDC and NFC) was seen in both groups. Mean IOP decrease from baseline for all IOP measurements was -9.13 to -7.30 mmHg in the FDC and -9.43 to -7.54 mmHg in the NFC group (PP analysis, p<0.0001 for both groups). At 6 months, the estimated overall treatment difference (FDC - NFC) in the PP analysis was 0.308 mmHg with a 95% CI from -0.194 to 0.810 mmHg (p=0.228). The upper limit of the CI was clearly below the pre-specified margin of 1.5 mmHg providing strong evidence on the non-inferiority between FDC and NFC. An IOP lowering effect of >30% from baseline was achieved at month 6 in 58.3% and 66.9% of patients treated with FDC and NFC respectively. Patients with related ocular AEs were evenly distributed between FDC and NFC groups (21.4% and 18.6%). Hyperaemia was reported in 16 patients (8.0%) in the FDC group and in 10 patients (5.0%) in the NFC group, and was generally of mild or moderate severity.

Conclusions: A substantial and comparable IOP reduction was seen both for FDC and NFC throughout the 6-month study period. Both, primary and secondary efficacy variables unanimously evidenced non-inferiority between the two treatment arms in reduction of IOP.

Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 506 eicosanoids • 503 drug toxicity/drug effects  
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