TY - JOUR

T1 - Adverse Effects and Safety in Glaucoma Patients

T2 - Agreement on Clinical Trial Outcomes for Reports on Eye Drops (ASGARD)—A Delphi Consensus Statement

AU - Thein, Anna Sophie

AU - Hedengran, Anne

AU - Azuara-Blanco, Augusto

AU - Arita, Reiko

AU - Cvenkel, Barbara

AU - Gazzard, Gus

AU - Heegaard, Steffen

AU - de Paiva, Cintia S.

AU - Petrovski, Goran

AU - Prokosch-Willing, Verena

AU - Utheim, Tor P.

AU - Virgili, Gianni

AU - Kolko, Miriam

N1 - Funding Information: Funding/Support: This study received no funding. Financial Disclosures: Reiko Arita holds patents on the infrared meibography technique (Japanese patent registration no. 5281846; US patent publication no. 2011-0273550A1; European patent publication no. 2189108A1), is a consultant for Topcon Company (Tokyo, Japan) and Technopia Japan (Tokyo, Japan); in addition, she has received lecture fees from Santen, Senju, Lumenis, Inami, J&J, Alcon, and Novartis. Gus Gazzard has received grants from Thea and Santen, consulting fees from Allergan, Belkin, Equinox, Genentech, Glaukos, Ivantis, McKinsey, Reichert, Santen, Sight Sciences, Thea, and Zeiss, and lecture fees from Alcon, Allergan, Belkin, Equinox, Genentech, Glaukos, Ivantis, McKinsey, Reichert, Santen, Sight Sciences, and Thea. Steffen Heegaard has received lecture fees from Alcon, Sanofi, Eye-GO, and Santen. Cintia S. de Paiva has received research grants from Yuyu Pharma, Allysta Pharma, and Roche. Goran Petrovski has received lecture fees from Allergan, Alcon, and Santen. Tor P. Utheim is cofounder and co-owner of The Norwegian Dry Eye Clinic and the Clinic of Eye Health, Oslo, Norway, which delivers talks for and/or receives financial support from the following: ABIGO, Alcon, Allergan, AMWO, Bausch&Lomb, Bayer, European School for Advanced Studies in Ophthalmology, InnZ Medical, Medilens Nordic, Medistim, Novartis, Santen, Specsavers, Shire Pharmaceuticals, and Thea Laboratories. He has served on the global scientific advisory board for Novartis and Alcon as well as the European advisory board for Shire Pharmaceuticals. In addition, he is the Norwegian Global Ambassador for Tear Film and Ocular Surface Society (TFOS), a Board Member of the International Ocular Surface Society, and a Consultant at the Norwegian Association for the Blind and Partially Sighted. Miriam Kolko has received lecture fees from Santen, Allergan/Abbvie, Thea Pharmaceutical, is an advisory board member in Allergan/Abbvie and Thea Pharmaceutical, an expert group member in Santen, has a collaboration grant from Thea Pharmaceutical, and is a consultant for Abbvie and Thea Pharmaceutical. The other authors indicate no financial support or conflicts of interest. All authors attest that they meet the current ICMJE criteria for authorship. Declaration of Competing Interest: The authors have no conflicts of interest to disclose related to the present study. Acknowledgments: The authors wish to acknowledge the contributions of survey participants in the ASGARD study group: Augusto Azuara-Blanco, Alex Day, Alexander Schuster, Anders Højslet Vestergaard, Andy McNaught, Anssam Jamal Assad Al-Shamary, Anthony King, Reiko Arita, Biljana Spaseva-Karanfilova, Barbara Cvenkel, Bek Tashbayev, Benjamin Frankfort, Christophe Baudouin, Cintia de Paiva, Jong-Suk Song, Ted Garway-Heath, Daniella Bach-Holm, Karl Mercieca, Erlend Sommer Landsend, Elisabeth Messmer, Eduardo Rocha, Carl Erb, Florian Rüfer, Frances Meier-Gibbons, Shima Fukuoka, Galina Dimitrova, Gianni Virgili, Goran Petrovski, Gus Gazzard, Gysbert-Botho van Setten, Hari Jayaram, Gabor Hollo, Ingrida Januleviciene, Ilgaz Yalvac, Jae Lim Chung, Jan Henrik Simonsen, Jeremias Galletti, Jim Kirwan, Jia Yin, Jayter de Paula, Jukka Moilanen, Kai Kaarniranta, Lars Loumann Knudsen, Ljubo Znaor, Manfred Zierhut, Matilda Chan, Miriam Kolko, Michael Læssø, Mohammed Kashaf Farooq, Monica Alves, Niko Setälä, Pavi Agrawal, Per Riise, Petra Schollmayer, Peter Fahmy, Philipp Steven, Simon Von Spreckelsen, Reza A. Badian, Saj Ahmed, Simona Nicoara, Søren Berndt Hansen, Stephen C Pflugfelder, Steffen Heegaard, Niklas Telinius, Troels Brynskov, Tor Utheim, Valeria Mocanu, Verena Prokosch-Willing, Vito Romano, Vladimir Poposki, Yolanda Diebold. Funding Information: Funding/Support: This study received no funding. Financial Disclosures: Reiko Arita holds patents on the infrared meibography technique (Japanese patent registration no. 5281846; US patent publication no. 2011-0273550A1; European patent publication no. 2189108A1), is a consultant for Topcon Company (Tokyo, Japan) and Technopia Japan (Tokyo, Japan); in addition, she has received lecture fees from Santen, Senju, Lumenis, Inami, J&J, Alcon, and Novartis. Gus Gazzard has received grants from Thea and Santen, consulting fees from Allergan, Belkin, Equinox, Genentech, Glaukos, Ivantis, McKinsey, Reichert, Santen, Sight Sciences, Thea, and Zeiss, and lecture fees from Alcon, Allergan, Belkin, Equinox, Genentech, Glaukos, Ivantis, McKinsey, Reichert, Santen, Sight Sciences, and Thea. Steffen Heegaard has received lecture fees from Alcon, Sanofi, Eye-GO, and Santen. Cintia S. de Paiva has received research grants from Yuyu Pharma, Allysta Pharma, and Roche. Goran Petrovski has received lecture fees from Allergan, Alcon, and Santen. Tor P. Utheim is cofounder and co-owner of The Norwegian Dry Eye Clinic and the Clinic of Eye Health, Oslo, Norway, which delivers talks for and/or receives financial support from the following: ABIGO, Alcon, Allergan, AMWO, Bausch&Lomb, Bayer, European School for Advanced Studies in Ophthalmology, InnZ Medical, Medilens Nordic, Medistim, Novartis, Santen, Specsavers, Shire Pharmaceuticals, and Thea Laboratories. He has served on the global scientific advisory board for Novartis and Alcon as well as the European advisory board for Shire Pharmaceuticals. In addition, he is the Norwegian Global Ambassador for Tear Film and Ocular Surface Society (TFOS), a Board Member of the International Ocular Surface Society, and a Consultant at the Norwegian Association for the Blind and Partially Sighted. Miriam Kolko has received lecture fees from Santen, Allergan/Abbvie, Thea Pharmaceutical, is an advisory board member in Allergan/Abbvie and Thea Pharmaceutical, an expert group member in Santen, has a collaboration grant from Thea Pharmaceutical, and is a consultant for Abbvie and Thea Pharmaceutical. The other authors indicate no financial support or conflicts of interest. All authors attest that they meet the current ICMJE criteria for authorship.

PY - 2022

Y1 - 2022

N2 - PURPOSE: The purpose of this study is to establish consensus among experts on outcomes and methods to be used in clinical trials to assess adverse effects of anti-glaucomatous eye drops. DESIGN: Modified Delphi method. METHODS: Clinical experts from Europe, North America, South America, the Middle East, and Asia were invited to participate in 2 sequential web-based surveys administered from June 27 to August 29, 2021. A total of 91 clinical experts were invited to participate. Of these, 71 (78%) experts from 23 different countries accepted the invitation and answered the first questionnaire. The importance of items was ranked using a 10-point scale (1 as not important, 10 as very important). RESULTS: A total of 84 items were rated in round one by 71 participants. Of these, 68 (81%) reached consensus. In round 2, 19 items, including 3 additional items, were rated by 53 (75%) participants. Consensus was reached in 98% of investigated items. Eight outcomes were agreed as important to assess when conducting future trials: ocular surface, dryness, epithelial damage, local adverse effects related to eye drops as reported by patients, periocular surroundings and eyelids, quality of life questionnaires, hyperemia, visual acuity, tear film, and anterior chamber inflammation. CONCLUSION: We propose a consensus-based series of outcomes and assessment methods to be used in clinical trials assessing adverse effects of antiglaucomatous eye drops. This, we hope, will improve the comparability of results from future trials and thus facilitate meta-analyses and progress in this field.

AB - PURPOSE: The purpose of this study is to establish consensus among experts on outcomes and methods to be used in clinical trials to assess adverse effects of anti-glaucomatous eye drops. DESIGN: Modified Delphi method. METHODS: Clinical experts from Europe, North America, South America, the Middle East, and Asia were invited to participate in 2 sequential web-based surveys administered from June 27 to August 29, 2021. A total of 91 clinical experts were invited to participate. Of these, 71 (78%) experts from 23 different countries accepted the invitation and answered the first questionnaire. The importance of items was ranked using a 10-point scale (1 as not important, 10 as very important). RESULTS: A total of 84 items were rated in round one by 71 participants. Of these, 68 (81%) reached consensus. In round 2, 19 items, including 3 additional items, were rated by 53 (75%) participants. Consensus was reached in 98% of investigated items. Eight outcomes were agreed as important to assess when conducting future trials: ocular surface, dryness, epithelial damage, local adverse effects related to eye drops as reported by patients, periocular surroundings and eyelids, quality of life questionnaires, hyperemia, visual acuity, tear film, and anterior chamber inflammation. CONCLUSION: We propose a consensus-based series of outcomes and assessment methods to be used in clinical trials assessing adverse effects of antiglaucomatous eye drops. This, we hope, will improve the comparability of results from future trials and thus facilitate meta-analyses and progress in this field.

KW - adverse effects

KW - consensus

KW - Delphi Study

KW - Glaucoma

KW - ocular surface

U2 - 10.1016/j.ajo.2022.05.007

DO - 10.1016/j.ajo.2022.05.007

M3 - Journal article

C2 - 35594917

AN - SCOPUS:85133293377

VL - 241

SP - 190

EP - 197

JO - American Journal of Ophthalmology

JF - American Journal of Ophthalmology

SN - 0002-9394

ER -