TY - JOUR
T1 - Randomized clinical trial of the efficacy and safety of preservative-free tafluprost and timolol in patients with open-angle glaucoma or ocular hypertension
AU - Chabi, Almira
AU - Varma, Rohit
AU - Tsai, James C.
AU - Lupinacci, Robert
AU - Pigeon, Joseph
AU - Baranak, Christine
AU - Noble, Liliane
AU - Lines, Christopher
AU - Ho, Tony W.
N1 - Funding Information:
All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Publication of this article was supported by funding from Merck, Whitehouse Station, New Jersey, USA. The sponsor was involved in the design, collection, analysis, and interpretation of the data; and the preparation and review of the manuscript. A.C., R.L., C.B., L.N., C.L., and T.W.H. are employees of Merck and own stock/stock options in Merck. R.V. has received consulting fees from Merck, Alcon, Allergan, Aquesys, Genentech, and Replenish, and research grants from NIH , Genentech , and Replenish . J.C.T. has received consulting fees and research grants from Merck . J.P. has received consulting fees from Merck. Involved in conception and design of the study (R.V., J.C.T., R.L., J.P., T.W.H.); analysis and interpretation of the data (A.C., R.V., J.C.T., R.L., J.P., C.B., L.N., C.L., T.W.H.); writing the article (A.C., R.L., C.L., T.W.H.); and revision and approval of the article (A.C., R.V., J.C.T., R.L., J.P., C.B., L.N., C.L., T.W.H.). The study and data accumulation were carried out with approval from the appropriate Institutional Review Boards and regulatory agencies for each site. Informed Consent for the research was obtained from the patients or subjects, and the study was in accordance with HIPAA regulations and the principles of Good Clinical Practice. The study was registered at ClinicalTrials.gov ( NCT01026831 ). The authors would like to thank Roger Hitchings (Moorfields Eye Hospital, United Kingdom) for advice about the study design and data interpretation.
PY - 2012/6
Y1 - 2012/6
N2 - Purpose: To compare the efficacy and safety of tafluprost, a preservative-free (PF) prostaglandin analogue, with PF timolol in patients with open-angle glaucoma or ocular hypertension. Design: Randomized, double-masked, multicenter clinical trial. Methods: After discontinuation and washout of existing ocular hypotensive treatment, patients who had intraocular pressure (IOP) <23 and ≤36 mm Hg in at least 1 eye at the 08:00 hour time point were randomized 1:1 to 12 weeks of treatment with either PF tafluprost 0.0015% or PF timolol 0.5%. IOP was measured 3 times during the day (08:00, 10:00, 16:00 hours) at baseline and at weeks 2, 6, and 12. It was hypothesized that PF tafluprost would be noninferior to PF timolol over 12 weeks with regard to change from baseline IOP. The trial was powered for a noninferiority margin of 1.5 mm Hg at each of the 9 time points assessed. Results: A total of 643 patients were randomized and 618 completed (PF tafluprost = 306, PF timolol = 312). IOPs at the 3 time points assessed during the baseline visit ranged from 23.8 to 26.1 mm Hg in the PF tafluprost group and 23.5 to 26.0 mm Hg in the PF timolol group. IOPs at the 3 time points assessed during the 12-week visit ranged from 17.4 to 18.6 mm Hg for PF tafluprost and 17.9 to 18.5 mm Hg for PF timolol. At all 9 time points, the upper limits of the 2-sided 95% confidence intervals for the difference between treatments in IOP lowering were less than the prespecified noninferiority margin. Similar percentages of PF tafluprost and PF timolol patients reported ocular pain/stinging/irritation (4.4% vs 4.6%) and pruritus (2.5% vs 1.5%). The percentages of PF tafluprost and PF timolol patients reporting conjunctival hyperemia were 4.4% vs 1.2% (nominal P =.016). Conclusions: The IOP-lowering effect of PF tafluprost was noninferior to that of PF timolol. PF tafluprost is an efficacious and generally well-tolerated ocular hypotensive agent.
AB - Purpose: To compare the efficacy and safety of tafluprost, a preservative-free (PF) prostaglandin analogue, with PF timolol in patients with open-angle glaucoma or ocular hypertension. Design: Randomized, double-masked, multicenter clinical trial. Methods: After discontinuation and washout of existing ocular hypotensive treatment, patients who had intraocular pressure (IOP) <23 and ≤36 mm Hg in at least 1 eye at the 08:00 hour time point were randomized 1:1 to 12 weeks of treatment with either PF tafluprost 0.0015% or PF timolol 0.5%. IOP was measured 3 times during the day (08:00, 10:00, 16:00 hours) at baseline and at weeks 2, 6, and 12. It was hypothesized that PF tafluprost would be noninferior to PF timolol over 12 weeks with regard to change from baseline IOP. The trial was powered for a noninferiority margin of 1.5 mm Hg at each of the 9 time points assessed. Results: A total of 643 patients were randomized and 618 completed (PF tafluprost = 306, PF timolol = 312). IOPs at the 3 time points assessed during the baseline visit ranged from 23.8 to 26.1 mm Hg in the PF tafluprost group and 23.5 to 26.0 mm Hg in the PF timolol group. IOPs at the 3 time points assessed during the 12-week visit ranged from 17.4 to 18.6 mm Hg for PF tafluprost and 17.9 to 18.5 mm Hg for PF timolol. At all 9 time points, the upper limits of the 2-sided 95% confidence intervals for the difference between treatments in IOP lowering were less than the prespecified noninferiority margin. Similar percentages of PF tafluprost and PF timolol patients reported ocular pain/stinging/irritation (4.4% vs 4.6%) and pruritus (2.5% vs 1.5%). The percentages of PF tafluprost and PF timolol patients reporting conjunctival hyperemia were 4.4% vs 1.2% (nominal P =.016). Conclusions: The IOP-lowering effect of PF tafluprost was noninferior to that of PF timolol. PF tafluprost is an efficacious and generally well-tolerated ocular hypotensive agent.
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U2 - 10.1016/j.ajo.2011.11.008
DO - 10.1016/j.ajo.2011.11.008
M3 - Article
C2 - 22310086
AN - SCOPUS:84861193144
SN - 0002-9394
VL - 153
SP - 1187
EP - 1196
JO - American journal of ophthalmology
JF - American journal of ophthalmology
IS - 6
ER -