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Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials

BACKGROUND: The aim of this study was to provide an integrated analysis of safety and efficacy data for brimonidine tartrate ophthalmic solution 0.025 per cent (low‐dose; Bausch & Lomb Incorporated), a topical vasoconstrictor for relief of ocular redness. METHODS: Integrated efficacy data from t...

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Autores principales: Ackerman, Stacey L, Torkildsen, Gail L, McLaurin, Eugene, Vittitow, Jason L
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wiley Publishing Asia Pty Ltd 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587872/
https://www.ncbi.nlm.nih.gov/pubmed/30525235
http://dx.doi.org/10.1111/cxo.12846
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author Ackerman, Stacey L
Torkildsen, Gail L
McLaurin, Eugene
Vittitow, Jason L
author_facet Ackerman, Stacey L
Torkildsen, Gail L
McLaurin, Eugene
Vittitow, Jason L
author_sort Ackerman, Stacey L
collection PubMed
description BACKGROUND: The aim of this study was to provide an integrated analysis of safety and efficacy data for brimonidine tartrate ophthalmic solution 0.025 per cent (low‐dose; Bausch & Lomb Incorporated), a topical vasoconstrictor for relief of ocular redness. METHODS: Integrated efficacy data from two randomised, double‐masked, vehicle‐controlled studies in subjects with ocular redness as well as safety data from the two efficacy studies, a vehicle‐controlled safety study, and a pharmacokinetic study were analysed. Efficacy outcomes analysed included investigator‐assessed ocular redness (scale, 0–4) before treatment instillation and at five to 240 minutes post‐instillation on Day 1, at five minutes post‐instillation on Days 15 and 29, and one week after treatment discontinuation (Day 36), and redness self‐assessed by subjects recorded daily in diaries. Safety assessments included adverse events, ophthalmic examinations, and rebound redness upon treatment discontinuation. Drop comfort (scale, 0–10) was a tolerability measure. RESULTS: The efficacy population included 117 subjects (brimonidine, n = 78; vehicle, n = 39). The safety population included 635 subjects (brimonidine, n = 426; vehicle, n = 209). Investigator‐assessed ocular redness was significantly lower with brimonidine versus vehicle at all post‐instillation time points on Day 1 (mean change from pre‐instillation of −1.4 units for brimonidine and −0.2 units for vehicle; p < 0.0001). Subject‐assessed ocular redness was also significantly lower with brimonidine versus vehicle (mean treatment difference in average daily ratings of −0.9; p < 0.0001). There was no evidence of tachyphylaxis through Day 29 and rebound redness was rare. Incidence of ocular adverse events was low, the most common being reduced visual acuity (brimonidine, 4.0 per cent; vehicle, 4.3 per cent) and conjunctival hyperaemia (2.6 and 2.9 per cent, respectively). Both brimonidine and vehicle were rated as very comfortable (mean post‐instillation scores, 0.4–0.5). CONCLUSION: In this integrated analysis, low‐dose brimonidine significantly reduced ocular redness with no tachyphylaxis, and minimal rebound redness, and was generally safe and well tolerated.
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spelling pubmed-65878722019-07-02 Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials Ackerman, Stacey L Torkildsen, Gail L McLaurin, Eugene Vittitow, Jason L Clin Exp Optom Research BACKGROUND: The aim of this study was to provide an integrated analysis of safety and efficacy data for brimonidine tartrate ophthalmic solution 0.025 per cent (low‐dose; Bausch & Lomb Incorporated), a topical vasoconstrictor for relief of ocular redness. METHODS: Integrated efficacy data from two randomised, double‐masked, vehicle‐controlled studies in subjects with ocular redness as well as safety data from the two efficacy studies, a vehicle‐controlled safety study, and a pharmacokinetic study were analysed. Efficacy outcomes analysed included investigator‐assessed ocular redness (scale, 0–4) before treatment instillation and at five to 240 minutes post‐instillation on Day 1, at five minutes post‐instillation on Days 15 and 29, and one week after treatment discontinuation (Day 36), and redness self‐assessed by subjects recorded daily in diaries. Safety assessments included adverse events, ophthalmic examinations, and rebound redness upon treatment discontinuation. Drop comfort (scale, 0–10) was a tolerability measure. RESULTS: The efficacy population included 117 subjects (brimonidine, n = 78; vehicle, n = 39). The safety population included 635 subjects (brimonidine, n = 426; vehicle, n = 209). Investigator‐assessed ocular redness was significantly lower with brimonidine versus vehicle at all post‐instillation time points on Day 1 (mean change from pre‐instillation of −1.4 units for brimonidine and −0.2 units for vehicle; p < 0.0001). Subject‐assessed ocular redness was also significantly lower with brimonidine versus vehicle (mean treatment difference in average daily ratings of −0.9; p < 0.0001). There was no evidence of tachyphylaxis through Day 29 and rebound redness was rare. Incidence of ocular adverse events was low, the most common being reduced visual acuity (brimonidine, 4.0 per cent; vehicle, 4.3 per cent) and conjunctival hyperaemia (2.6 and 2.9 per cent, respectively). Both brimonidine and vehicle were rated as very comfortable (mean post‐instillation scores, 0.4–0.5). CONCLUSION: In this integrated analysis, low‐dose brimonidine significantly reduced ocular redness with no tachyphylaxis, and minimal rebound redness, and was generally safe and well tolerated. Wiley Publishing Asia Pty Ltd 2018-12-07 2019-03 /pmc/articles/PMC6587872/ /pubmed/30525235 http://dx.doi.org/10.1111/cxo.12846 Text en © 2018 The Authors. Clinical and Experimental Optometry published by John Wiley & Sons Australia, Ltd on behalf of Optometry Australia This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research
Ackerman, Stacey L
Torkildsen, Gail L
McLaurin, Eugene
Vittitow, Jason L
Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
title Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
title_full Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
title_fullStr Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
title_full_unstemmed Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
title_short Low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
title_sort low‐dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587872/
https://www.ncbi.nlm.nih.gov/pubmed/30525235
http://dx.doi.org/10.1111/cxo.12846
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