Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma

Summary

This project purpose is to evaluate the effectiveness, ocular surface quality, medication adherence and quality of life in 46 glaucoma patients in use of three separate drugs (Bimatoprost 0.3%, Timolol Maleate 0.5% and Brimonidine Tartrate 0.2%) comparing with triple combination, Triplenex. In this clinical trial approved by the Unifesp Etical and Research Comitte, volunteer glaucoma patients will be recruited from Unifesp Glaucoma Sector and VerMais Glaucoma Sector. They will be randomly divided em two groups,Group I is going to be treated with Triplenex (1 drop twice a day) and Grupo II with Brimonidine Tartarate (1 drop twice a day), Timolol Maleate (1 drop twice a day) and Bimatoprost (1 drop at night). At baseline visit a complete ophthalmolgical exam will be performed along with three questionnaires ("Ocular Surface Disease Index", "Glaucoma Treatment Compliance Assessment Tool" and "National Eye Institute Visual Function Questionnaire"),retinography, visual field, optic nerve OCT in all patients. This procedure will be repeated at baseline and within 4, 8, 12 weeks.

Timeline

Start

2021-03-01

Primary completion

2024-12-10

Completion

2025-02-26

Publications

• Background The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
• Background Goldberg I, Clement CI, Chiang TH, Walt JG, Lee LJ, Graham S, Healey PR. Assessing quality of life in patients with glaucoma using the Glaucoma Quality of Life-15 (GQL-15) questionnaire. J Glaucoma. 2009 Jan;18(1):6-12. doi: 10.1097/IJG.0b013e3181752c83.
• Background Baffa Ldo P, Ricardo JR, Dias AC, Modulo CM, Braz AM, Paula JS, Rodrigues Mde L, Rocha EM. Tear film and ocular surface alterations in chronic users of antiglaucoma medications. Arq Bras Oftalmol. 2008 Jan-Feb;71(1):18-21. doi: 10.1590/s0004-27492008000100004.
• Background Skalicky SE, Goldberg I, McCluskey P. Ocular surface disease and quality of life in patients with glaucoma. Am J Ophthalmol. 2012 Jan;153(1):1-9.e2. doi: 10.1016/j.ajo.2011.05.033. Epub 2011 Aug 26.
• Background Fechtner RD, Godfrey DG, Budenz D, Stewart JA, Stewart WC, Jasek MC. Prevalence of ocular surface complaints in patients with glaucoma using topical intraocular pressure-lowering medications. Cornea. 2010 Jun;29(6):618-21. doi: 10.1097/ICO.0b013e3181c325b2.
• Background Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.
• Background Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.
• Background Olthoff CM, Schouten JS, van de Borne BW, Webers CA. Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005 Jun;112(6):953-61. doi: 10.1016/j.ophtha.2004.12.035.
• Background Mansberger SL, Sheppler CR, McClure TM, Vanalstine CL, Swanson IL, Stoumbos Z, Lambert WE. Psychometrics of a new questionnaire to assess glaucoma adherence: the Glaucoma Treatment Compliance Assessment Tool (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2013 Sep;111:1-16.
• Background Belfort R Jr, Paula JS, Lopes Silva MJ, Della Paolera M, Kim T, Chen MY, Goodkin ML. Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆. Clin Ther. 2020 Feb;42(2):263-275. doi: 10.1016/j.clinthera.2019.12.008. Epub 2020 Feb 20.
• Background Hartleben C, Parra JC, Batoosingh A, Bernstein P, Goodkin M. A Masked, Randomized, Phase 3 Comparison of Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol versus Fixed-Combination Brimonidine/Timolol for Lowering Intraocular Pressure. J Ophthalmol. 2017;2017:4586763. doi: 10.1155/2017/4586763. Epub 2017 Sep 19.

Drugs

Indications