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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.
This clinical study aims to compare the use of the hypotensive eye drop Triplenex, a fixed triple combination (currently available only in Brazil, Mexico, and Chile), with the globally recognized combination of the same drugs administered separately. The combination of the eye drops Bimatoprost 0.3%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2% in separate vials is traditionally used in patients with difficult intraocular pressure control or advanced glaucoma that requires a low target pressure for proper disease management. The fixed triple combination intends to improve patient adherence while maintaining the efficacy of intraocular pressure control and progression of glaucoma. This study arises in the context of a lack of literature comparing Triplenex to the three original drugs and the absence of data on its influence on adherence, ocular surface, and the quality of life in the daily lives of glaucoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Triplenex (Triple Fixed Combination Eyedrop) | Experimental | After the visit during which their previous hypotensive eye drops are suspended, thus determining the baseline intraocular pressure and the ocular surface at this moment, the patients will be randomized. The experimental group (Group I) is going to be treated with Triplenex (a combination of the three drugs included in the control group), patients will be instructed to use 1 drop twice a day . |
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| Group II: Brimonidine Tartarate 0.2%, Timolol Maleate 0.5%, Bimatoprost 0.03% | Other | After the visit during which their previous hypotensive eye drops are suspended, thus determining the baseline intraocular pressure and the ocular surface at this moment, the patients will be randomized. The control group (Group II) is going to be treated with a combination of three separated eyedrops: Brimonidine Tartarate 0.2%,Timolol Maleate 0.5%, Bimatoprost 0.03%. The dosage for the eye drops Brimonidine Tartarate and Timolol Maleate will be twice a day. The drug Bimatoprost is advised to be instilled once at night. The use of the combination of the three separate drugs is instructed with a time interval of at least 10 minutes between each class of eye drop. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triple combination formula | Drug | Individuals 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial | Compare the efficacy of Triplenex (fixed triple combination) to the same substances separated into three eye drops (Bimatoprost 0.03%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2%). The comparison of efficacy between the groups will be evaluated based on the reduction of intraocular pressure and control of glaucoma progression. | From enrollment to the end of treatment at 6 months |
| Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial | Compare the adverse effects of Triplenex (fixed triple combination) to the same substances separated into three eye drops (Bimatoprost 0.03%, Timolol Maleate 0.5%, and Brimonidine Tartrate 0.2%). The side effects will be mesured by the following assessments: ocular surface assessment (conjunctival hyperemia, tear film break-up time, keratitis) and (Ocular Surface Disease Index) questionnaire. Conjunctival hyperemia and keratitis are measured on a 5-level scale, with the last level being the worst classification. Tear film break-up time is measured in time from 0 to 10 seconds, the longer the tear film takes to break the better the result. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial | Compare the adherence to the treatment of glaucoma patients using the fixed combination to the use of the same three drugs separately. A compliance questionnaire (Glaucoma Treatment Compliance Assessment Tool) score will be used in comparison between groups. | From enrollment to the end of treatment at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolina Gracitelli, Affiliate Professsor | Federal University of São Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of São Paulo | São Paulo | São Paulo | 04021001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17508116 | 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. | |
| 19142128 | 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. |
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Data sheet that does not identify the patient, and also the statistic analyses.
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Not provided
| ID | Term |
|---|---|
| D013999 | Timolol |
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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|
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| Bimatoprost .03% sterile ophthalmic solution | Drug | Individuals 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 0.2%(1 drop twice a day), Timolol Maleate 0.5% (1 drop twice a day) and Bimatoprost 0.3% (1 drop at night). At the first visit a complete ophthalmolgical exam which includes ocular surface items (conjunctival hiperemia, keratitis and tear film break up time). Questionnaires are performed ("Ocular Surface Disease Index", "Glaucoma Treatment Compliance Assessment Tool" and "National Eye Institute Visual Function Questionnaire") to assess information about ocular surface adverse effects, quality of life and treatment adherence. Glaucoma exams as retinography, perimetry, optic nerve OCT (optical coherence tomography), central corneal thickness are performed on all patients to evaluate disease's control. This procedure will be repeated at all visits: baseline and within 4, 8, 12 weeks. |
|
|
| Triplenex (triple fixed combination) use evaluation in patients with Glaucoma: randomized clinical trial | Compare the quality of life of patients using the triple fixed combination to the use of the same three drugs separately. A quality of life questionnaire (Visual Function Questionnaire-25) will be performed every visit generating a score that will be used in the comparison between groups, in this scale a higher score means better quality of life. | From enrollment to the end of treatment at 6 months |
| 18408831 | 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. |
| 21872203 | 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. |
| 20386433 | 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. |
| 11448327 | 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. |
| 25912144 | 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. |
| 15885795 | 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. |
| 24072942 | 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. |
| 32089329 | 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. |
| 29057117 | 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. |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D000577 | Amides |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |