TY - JOUR
T1 - Intraocular Pressure Following Prerandomization Glaucoma Medication Washout in the HORIZON and COMPASS Trials
AU - Johnson, Thomas V.
AU - Jampel, Henry D.
N1 - Funding Information:
Funding/Support: The Wilmer Eye Institute is supported by an unrestricted grant from Research to Prevent Blindness (New York, New York, USA). Financial Disclosures: Henry D. Jampel: Allergan (equity); American Academy of Ophthalmology (compensation for editorial work). Thomas V. Johnson has no financial disclosures. All authors attest that they meet the current ICMJE criteria for authorship.
Funding Information:
Funding/Support: The Wilmer Eye Institute is supported by an unrestricted grant from Research to Prevent Blindness (New York, New York, USA). Financial Disclosures: Henry D. Jampel: Allergan (equity); American Academy of Ophthalmology (compensation for editorial work). Thomas V. Johnson has no financial disclosures. All authors attest that they meet the current ICMJE criteria for authorship. Other Acknowledgments: The authors are grateful to Ivantis Inc (Irvine, California, USA) and Alcon (Ft Worth, Texas, USA) for sharing prerandomization study data from the HORIZON and COMPASS trials, respectively. No representatives from these companies participated in drafting this manuscript or the data analyses contained herein.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/8
Y1 - 2020/8
N2 - Purpose: To assess the effectiveness of topical ocular hypotensive medications in patients with open-angle glaucoma and to identify factors associated with postwashout intraocular pressure (IOP) elevation. Design: Secondary analysis of prerandomization data from 2 prospective, multicenter, randomized clinical trials. Methods: Fourteen hundred subjects (1,400 eyes, 781 from the HORIZON study of the Hydrus micro-stent and 619 from the COMPASS study of the Cypass micro-stent) with primary open-angle glaucoma who were using 0-4 classes of topical IOP-lowering medication underwent Goldmann applanation tonometry before and after a protocol-defined washout period. Results: The mean (standard deviation) age was 70.7 (8.0) years and 55.6% were female. The change in IOP following washout for patients using 0 (n = 100), 1 (n = 705), 2 (n = 355), 3 (n = 214), or 4 (n = 26) medications was 0.2 (2.8), 5.7 (3.3), 6.9 (3.7), 8.8 (5.0), and 9.5 (4.1) mm Hg, respectively (P < .001, Kruskal-Wallis test). Postwashout IOP change was similar between the HORIZON and COMPASS cohorts. No difference in postwashout IOP change was detected among individual prostaglandin analogues in patients on monotherapy. A generalized linear model identified the following factors to be associated with greater IOP rise upon medication washout: greater number of glaucoma medications, higher unmedicated IOP, thinner central corneal thickness (CCT), lack of prior selective laser trabeculoplasty (SLT), and male sex. Conclusions: Cessation of glaucoma medications results in a dose-dependent IOP increase in treated open-angle glaucoma patients. Two independent clinical trial cohorts exhibit similar levels of IOP elevation upon washout, using standardized methodology to estimate real-world medication effectiveness. Thicker CCT and history of SLT may predict reduced response to IOP lowering medications.
AB - Purpose: To assess the effectiveness of topical ocular hypotensive medications in patients with open-angle glaucoma and to identify factors associated with postwashout intraocular pressure (IOP) elevation. Design: Secondary analysis of prerandomization data from 2 prospective, multicenter, randomized clinical trials. Methods: Fourteen hundred subjects (1,400 eyes, 781 from the HORIZON study of the Hydrus micro-stent and 619 from the COMPASS study of the Cypass micro-stent) with primary open-angle glaucoma who were using 0-4 classes of topical IOP-lowering medication underwent Goldmann applanation tonometry before and after a protocol-defined washout period. Results: The mean (standard deviation) age was 70.7 (8.0) years and 55.6% were female. The change in IOP following washout for patients using 0 (n = 100), 1 (n = 705), 2 (n = 355), 3 (n = 214), or 4 (n = 26) medications was 0.2 (2.8), 5.7 (3.3), 6.9 (3.7), 8.8 (5.0), and 9.5 (4.1) mm Hg, respectively (P < .001, Kruskal-Wallis test). Postwashout IOP change was similar between the HORIZON and COMPASS cohorts. No difference in postwashout IOP change was detected among individual prostaglandin analogues in patients on monotherapy. A generalized linear model identified the following factors to be associated with greater IOP rise upon medication washout: greater number of glaucoma medications, higher unmedicated IOP, thinner central corneal thickness (CCT), lack of prior selective laser trabeculoplasty (SLT), and male sex. Conclusions: Cessation of glaucoma medications results in a dose-dependent IOP increase in treated open-angle glaucoma patients. Two independent clinical trial cohorts exhibit similar levels of IOP elevation upon washout, using standardized methodology to estimate real-world medication effectiveness. Thicker CCT and history of SLT may predict reduced response to IOP lowering medications.
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U2 - 10.1016/j.ajo.2020.04.008
DO - 10.1016/j.ajo.2020.04.008
M3 - Article
C2 - 32289292
AN - SCOPUS:85085282608
SN - 0002-9394
VL - 216
SP - 110
EP - 120
JO - American journal of ophthalmology
JF - American journal of ophthalmology
ER -