In:
European Journal of Ophthalmology, SAGE Publications, Vol. 19, No. 2 ( 2009-03), p. 214-222
Abstract:
This study investigated the efficacy and safety of tafluprost as an adjunctive therapy to timolol in patients with open-angle glaucoma or ocular hypertension, uncontrolled by timolol monotherapy. Methods This was a randomized, double-masked, parallel-group, multinational and multicenter 12-week phase III study. Tafluprost 0.0015% (once daily: 20:10) or vehicle were administered as adjunctive therapy to timolol 0.5% (twice daily: 08:00 and 20:00) for 6 weeks, after which all patients received tafluprost for 6 weeks. Intraocular pressure (IOP) measurements were conducted at 08:00, 10:00, and 16:00 at baseline, and weeks 2, 4, 6, and 12. Results A total of 185 patients were randomized to tafluprost (n = 96) or vehicle (n = 89). Reductions in IOP were seen in both groups, which were consistently more pronounced with tafluprost. At week 6, the change from baseline in diurnal IOP ranged from −5.49 to −5.82 mm Hg, and the overall treatment difference (tafluprost vehicle) was −1.49 mmHg (upper 95% confidence interval, −0.66; p 〈 0.001, intention-to-treat population, repeated measurements of the analysis of covariance model). At week 12, the change from baseline ranged from −6.22 to −6.79 mmHg in the tafluprost group. Patients switched from vehicle to tafluprost achieved a similar decrease in IOP to those who received tafluprost throughout the study (group difference at 12 weeks, −0.09 mmHg, p=0.812). There were more ocular adverse events with tafluprost compared with vehicle (42% vs. 29%, respectively), but most were mild in severity. Conclusions As adjunctive therapy to timolol, tafluprost achieved a consistently greater reduction in IOP compared with vehicle, and was well tolerated.
Type of Medium:
Online Resource
ISSN:
1120-6721
,
1724-6016
DOI:
10.1177/112067210901900207
Language:
English
Publisher:
SAGE Publications
Publication Date:
2009
detail.hit.zdb_id:
1475018-1
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