Page 7 - DUOKOPT BIBLIOBOOK
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EFFICACY


                                            STUDY CLAIMS



                   Authors, title, Journal, Year, Ref                          Study type / Claims

     Usability Testing Report for Medical Device. TIM (Transparence et Information du
                                                                                        ®
     Médicament)                                                      The innovative bottle Easygrip  is easy to use for patients.
     (According to ISO IEC 62366:2007) Jun 2013.
     Usability Testing Report for Medical Device.
                                                                                                                 ®
                                                                                                    ®
                                                                            ®
     TIM Transparence et Information du Médicament. (According to ISO IEC   The new bottle Easygrip  is easier to use compared to COMOD  and Control gripTM .
     62366:2007) Jun 2013.
     European real-world data about the use of a new delivery system containing a
                                      ®
                                                                                          ®
     preservative-free multi-dose glaucoma treatment .        The New Preservative-Free Multidose Easygrip  is easy to use by glaucoma patients.
     Denis P; et al. European Journal of Ophthalmology.2020 May;0(0) 1-8.
     A randomized trial comparing the dorzolamide-timolol combination given twice    Dorzolamide-Timolol fixed combination is more efficient in lowering IOP then Dorzola-
     daily to monotherapy with timolol and dorzolamide.                  mide on Timolol administered as monotherapy.
     Boyle JE, et al. Ophthalmology. 1998 Oct;105(10):1945-51.
     The safety and efficacy of brinzolamide 1% timolol 0.5% fixed combination versus   Brinzolamide-Timolol and Dorzolamide-Timolol fixed combination provide the same IOP
     dorzolamide 2% timolol 0.5% in patients with OAG or OH.                      lowering efficacy.
      Manni G, et al. J Glaucoma. 2009 Apr-May; 18(4):293-300.
     Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination
     compared with the brimonidine/timolol-fixed combination in primary open-angle  Dorzolamide-Timolol fixed combination is more efficient on 24-hour IOP than Brimoni-
     glaucoma.                                                                dine-Timolol fixed combination.
     Konstas AG, et al. Eye (Lond). 2012 Jan; 26(1):80 7.
     Intraocular pressure-lowering effects of commonly used fixed-combination drugs   Among fixed combinations with timolol, Dorzolamide-Timolol has a similar efficacy on
     with timolol: a systematic review and meta-analysis.       IOP compared to Brimonidine and Brinzolamide combinations with Timolol.
     Cheng JW, et al. PLoS One. 2012;7(9):e45079.
     Effect of Dorzolamide Timolol Combination Versus Timolol 0.5% on Ocular Bloo-  Dorzolamide-Timolol fixed combination reduces IOP and increases ocular
     dflow in Patients With Primary Open-angle Glaucoma.                     blood flow compared to Timolol.
     Harris A, et al. Am J Ophthalmol 2001; 132:490–495.
     Effects of dorzolamide 2% added to timolol maleate 0.5% on intraocular pressure,
     retrobulbar blood flow, and the progression of visual field damage in patients with   Dorzolamide-Timolol fixed combination shows a reduction IOP even in the long term.
     primary open-angle glaucoma: a single-center, 4-year, open-label study.
     Martínez A, et al. Clin Ther. 2008 Jun; 30(6):1120-34.
     Visual function, optic nerve structure, and ocular blood flow parameters after 1    1-Year treatment of Dorzolamide-Timolol fixed combination permits IOP reduction, a
     year of glaucoma treatment with fixed combinations.              stable visual function and a higher optic nerve perfusion.
     Januleviciene I, et al. Eur J Ophthalmol. 2009 Sep-Oct;19(5):790-7.
     Predictors for visual field progression and the effects of treatment with dorzola-
     mide 2% or brinzolamide 1% each added to timolol 0.5% in primary open-angle   Treatment with Dorzolamide-Timolol reduces the risk of visual field progression.
     glaucoma.
     Martinez A, et al. Acta Ophthalmol. 2010: 88: 541–552. 3.
     Comparison of the effects of dorzolamide/timolol and latanoprost/timolol fixed
     combinations upon intraocular pressure and progression of visual field damage in   Dorzodamide-Timolol fixed combination in long-term treatment is effective to reduce
     primary open-angle glaucoma.                                         IOP and in preventing visual field progression.
     Pajic B, et al. CMRO. 2010 Sep;26(9):2213-9.
     Comparison of Cytotoxic Effects on Rabbit Corneal Endothelium between Preser-  Preservative-free Dorzodamide-Timolol has a safer profile than the preserved fixed
     vative-free and Preservative-containing Dorzolamide/ timolol.                 combination.
     Kwon J, et al. Korean J Ophthalmol 2015;29(5):344-350
     Comparison of the efficacy and tolerability of preservative-free and preser-
     vative-containing formulations of the dorzolamide/timolol fixed combination   Preservative-free Dorzolamide-Timolol has a similar efficacy as the preserved fixed com-
     (COSOPT™) in patients with elevated intraocular pressure in a randomized clinical   bination but with a better tolerance.
     trial.
     Shedden A, et al. Graefes Arch Clin Exp Ophthalmol. 2010 Dec;248(12):1757-64.
     Efficacy and tolerability of preservative-free eye drops containing a fixed combi-  Switching from preserved treatment to unpreserved Dorzolamide-Timolol fixed combi-
     nation of dorzolamide and timolol in glaucoma patients.                 nation improves local tolerability.
     Renieri G, et al. J Ocul Pharmacol Ther. 2010 Dec;26(6):597-603.
     Tolerability and effectiveness of PF dorzolamide-timolol (PF COSOPT) in patients   In newly diagnosed patients, PF Dorzolamide-Timolol combination does not increase
     with open-angle glaucoma or ocular hypertension.        eye discomfort and contributes to both high patient's and ophthalmogist's satisfaction.
     Hutnik C, et al. Clin Ophthalmol. 2010 Jul 21;4:581-90.
     Improvement in glaucoma patients quality of life by therapy switch to preservative   Switching from preserved to preservative-free Dorzolamide-Timolol combination impro-
     free timolol/dorzolamide fixed combination (The CosoptUD Study Group)   ves ocular surface symptoms and patient's vision related to quality of life.
     Pinto LA, et al. Ophthalmologica - Published on line December 2013.
     Second-line therapy with dorzolamide/timolol or latanoprost/timolol fixed
     combination versus adding dorzolamide/timolol fixed combination to latanoprost  Tritherapy with latanoprost in addition to Dorzolamide-Timolol combination provides an
     monotherapy.                                                   additionnal 24h IOP reduction than Dorzolamide-Timolol alone.
     Konstas AG, et al. Br J Ophthalmol. 2008 Nov;92(11):1498-502.

                                                    Table 2 - Study claims


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