Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial
| Autor: | Rhett M. Schiffman, Marina Bejanian, Gail F. Schwartz, Douglas G. Day, Charlie Liu, Thomas R Walters, Thomas K Mundorf |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Intraocular pressure genetic structures Ocular surface Population Visual Acuity Glaucoma Ocular hypertension Tonometry Ocular Cellular and Molecular Neuroscience Double-Blind Method Ophthalmology medicine Humans Prospective Studies Preservative free education Antihypertensive Agents Aged Aged 80 and over education.field_of_study Bimatoprost business.industry Preservatives Pharmaceutical Cloprostenol Clinical Science Middle Aged medicine.disease Amides eye diseases Sensory Systems Safety profile Therapeutic Equivalency Female Ocular Hypertension Treatment Medical sense organs Ophthalmic Solutions business medicine.drug |
| Zdroj: | The British Journal of Ophthalmology |
| ISSN: | 1468-2079 0007-1161 |
| DOI: | 10.1136/bjophthalmol-2012-303040 |
| Popis: | Background/Aim To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. Methods In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. Results 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was |
| Databáze: | OpenAIRE |
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