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Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.
- Source :
- Advances in Therapy; Jun2018, Vol. 35 Issue 6, p796-808, 13p
- Publication Year :
- 2018
-
Abstract
- <bold>Introduction: </bold>This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM).<bold>Methods: </bold>This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire.<bold>Results: </bold>In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (nā=ā60) or LAT/TIM (nā=ā55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group.<bold>Conclusion: </bold>TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores.<bold>Trial Registration: </bold>UMIN Clinical Trials Registry Identifier, UMIN000023862.<bold>Funding: </bold>Santen Pharmaceutical Co., Ltd., Osaka, Japan. [ABSTRACT FROM AUTHOR]
- Subjects :
- PROSTAGLANDINS
ANTIHYPERTENSIVE agents
RESEARCH
GLAUCOMA
INTRAOCULAR pressure
SYNTHETIC prostaglandins F
COMBINATION drug therapy
OPTIC nerve diseases
OCULAR hypertension
RESEARCH methodology
EVALUATION research
MEDICAL cooperation
COMPARATIVE studies
RANDOMIZED controlled trials
TIMOLOL maleate
TONOMETRY
LONGITUDINAL method
Subjects
Details
- Language :
- English
- ISSN :
- 0741238X
- Volume :
- 35
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- Advances in Therapy
- Publication Type :
- Academic Journal
- Accession number :
- 130300123
- Full Text :
- https://doi.org/10.1007/s12325-018-0718-9