Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India

a phase III clinical trial

A. Chabi, C. Baranak, R. Lupinacci, W. J. Herring

Research output: Contribution to journalArticle

Abstract

Aim: The aim of this study was to evaluate the efficacy and safety of preservative-free (PF) tafluprost compared with PF timolol in Indian subjects with open-angle glaucoma (OAG) or ocular hypertension. Methods: This was a randomised, multicentre, double-masked, phase III trial. Subjects aged 18–80 years, following washout of current medication, with intraocular pressure (IOP) ≥ 24 and ≤ 36 mmHg in at least one eye were randomised in a 1:1 ratio to 0.0015% PF tafluprost or 0.5% PF timolol for 4 weeks. IOP was measured at 08:00, 10:00 and 16:00 hours at baseline and at weeks 2 and 4. The primary efficacy end-point was the mean diurnal IOP change from baseline at week 4, and PF tafluprost was considered non-inferior to PF timolol if the upper bound of the 95% confidence interval (CI) for between-treatment differences was ≤ 1.5 mmHg. The secondary end-point was the proportion of subjects with ≥ 25% reduction in IOP from baseline at week 4. Results: In total, 190 subjects were randomised, 95 each, to PF tafluprost and PF timolol treatment. PF tafluprost was non-inferior to PF timolol with respect to diurnal IOP changes from baseline over 4 weeks. The mean PF tafluprost-PF timolol difference in the diurnal IOP change was −1.7 (95% CI −2.6 to −0.7), suggestive of superiority for PF tafluprost. The secondary end-point was achieved in a higher proportion of PF tafluprost group subjects. Both PF tafluprost and PF timolol were well-tolerated with similar incidences of adverse events. Conclusions: PF tafluprost was safe and efficacious in reducing IOP in Indian subjects.

Original languageEnglish (US)
Pages (from-to)577-586
Number of pages10
JournalInternational Journal of Clinical Practice
Volume70
Issue number7
DOIs
StatePublished - Jul 1 2016
Externally publishedYes

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Ocular Hypertension
Phase III Clinical Trials
Open Angle Glaucoma
Timolol
India
Intraocular Pressure
tafluprost
Confidence Intervals
Safety

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Preservative-free tafluprost in the treatment of open-angle glaucoma or ocular hypertension in India : a phase III clinical trial. / Chabi, A.; Baranak, C.; Lupinacci, R.; Herring, W. J.

In: International Journal of Clinical Practice, Vol. 70, No. 7, 01.07.2016, p. 577-586.

Research output: Contribution to journalArticle

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abstract = "Aim: The aim of this study was to evaluate the efficacy and safety of preservative-free (PF) tafluprost compared with PF timolol in Indian subjects with open-angle glaucoma (OAG) or ocular hypertension. Methods: This was a randomised, multicentre, double-masked, phase III trial. Subjects aged 18–80 years, following washout of current medication, with intraocular pressure (IOP) ≥ 24 and ≤ 36 mmHg in at least one eye were randomised in a 1:1 ratio to 0.0015{\%} PF tafluprost or 0.5{\%} PF timolol for 4 weeks. IOP was measured at 08:00, 10:00 and 16:00 hours at baseline and at weeks 2 and 4. The primary efficacy end-point was the mean diurnal IOP change from baseline at week 4, and PF tafluprost was considered non-inferior to PF timolol if the upper bound of the 95{\%} confidence interval (CI) for between-treatment differences was ≤ 1.5 mmHg. The secondary end-point was the proportion of subjects with ≥ 25{\%} reduction in IOP from baseline at week 4. Results: In total, 190 subjects were randomised, 95 each, to PF tafluprost and PF timolol treatment. PF tafluprost was non-inferior to PF timolol with respect to diurnal IOP changes from baseline over 4 weeks. The mean PF tafluprost-PF timolol difference in the diurnal IOP change was −1.7 (95{\%} CI −2.6 to −0.7), suggestive of superiority for PF tafluprost. The secondary end-point was achieved in a higher proportion of PF tafluprost group subjects. Both PF tafluprost and PF timolol were well-tolerated with similar incidences of adverse events. Conclusions: PF tafluprost was safe and efficacious in reducing IOP in Indian subjects.",
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