دورية أكاديمية
Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension.
| العنوان: | Phase Ⅰ/Ⅱ, Double-Masked, Randomized, Vehicle-Controlled Study of H-1337 Ophthalmic Solution for Glaucoma and Ocular Hypertension. |
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| المؤلفون: | Hartman PJ; Rochester Ophthalmological Group, Rochester, New York., Cooke DL; Great Lakes Eye Care, St Joseph, Michigan., Hsu HH; Allysta Pharmaceuticals, Inc., Seattle, Washington., Stewart J; Allysta Pharmaceuticals, Inc., Seattle, Washington., Sumi K; D. Western Therapeutics Institute, Inc., Nagoya, Japan; Human Research Promotion and Drug Development, Mie University, Mie, Japan., Yoshida Y; D. Western Therapeutics Institute, Inc., Nagoya, Japan; Human Research Promotion and Drug Development, Mie University, Mie, Japan., Hidaka H; D. Western Therapeutics Institute, Inc., Nagoya, Japan; Human Research Promotion and Drug Development, Mie University, Mie, Japan., Novack GD; PharmaLogic Development, Inc., San Rafael, California; Department of Ophthalmology & Vision Science, University of California School of Medicine, Davis, California. Electronic address: gary_novack@pharmalogic.com. |
| المصدر: | Ophthalmology. Glaucoma [Ophthalmol Glaucoma] 2023 Mar-Apr; Vol. 6 (2), pp. 198-205. Date of Electronic Publication: 2022 Aug 31. |
| نوع المنشور: | Randomized Controlled Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101730510 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2589-4196 (Electronic) Linking ISSN: 25894196 NLM ISO Abbreviation: Ophthalmol Glaucoma Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York : Elsevier Inc., [2018]- |
| مواضيع طبية MeSH: | Glaucoma, Open-Angle*/drug therapy , Ocular Hypertension*/drug therapy , Glaucoma*/chemically induced, Humans ; Ophthalmic Solutions ; Intraocular Pressure |
| مستخلص: | Purpose: To perform a phase Ⅰ/Ⅱ evaluation of an H-1337 ophthalmic solution in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Design: This was a phase I/II, randomized, double-masked, vehicle-controlled, dose-response study conducted at 6 private practice sites in the United States. The study was registered with clinicaltrials.gov as NCT03452033. Participants: Eighty-seven subjects with bilateral POAG or OHT were enrolled. Methods: After washout of ocular hypotensive medications as required, the subjects were randomized to receive either the H-1337 ophthalmic solution at 0.06%, 0.2%, and 0.6% or its vehicle twice daily unilaterally in the study eye for the first 3 days and then twice daily in both eyes from day 4 to 28. Main Outcome Measures: The primary efficacy end point was the mean change in intraocular pressure from baseline (day 0) for each group on day 28 at hour 4 compared with the vehicle. Results: In the primary efficacy end point, i.e., mean change from the baseline on day 28 at hour 4, the mean change from the baseline was - 4.45 ± 3.801, - 5.16 ± 3.114, - 4.93 ± 3.110, and - 0.39 ± 2.355 in the 0.06%, 0.2%, and 0.6% H-1337 and vehicle groups, respectively. The difference between each active group and the vehicle group was statistically significant (P < 0.0001). Treatment-emergent adverse events (TEAEs) occurred in 49% of subjects who received H-1337 (range, 41% [0.2% arm]-64% [0.6% arm] across the H-1337 arms) and 18% of subjects who received the vehicle. The majority of TEAEs were mild in severity; 3 subjects who received H-1337 had a TEAE of moderate intensity (instillation site erythema, blurred vision, and muscle strain). Conclusions: The H-1337 ophthalmic solution showed clinically and statistically significant ocular hypotensive activity and was well tolerated, with a relatively low incidence of hyperemia. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. (Copyright © 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: First in human; H-1337; glaucoma; intraocular pressure; ocular hypertension |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03452033 |
| المشرفين على المادة: | 0 (Ophthalmic Solutions) |
| تواريخ الأحداث: | Date Created: 20220902 Date Completed: 20230327 Latest Revision: 20230424 |
| رمز التحديث: | 20230425 |
| DOI: | 10.1016/j.ogla.2022.08.015 |
| PMID: | 36055467 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2589-4196 |
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| DOI: | 10.1016/j.ogla.2022.08.015 |