A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study.

Autor: Mansberger SL; Chenoweth Chair of Ophthalmology and Director of Glaucoma Services at Legacy Devers Eye Institute, Portland, OR, United States of America. Electronic address: SMansberger@deverseye.org., Fechtner R; Chairman of the Department of Ophthalmology, SUNY Upstate Medical University, Syracuse, NY, United States of America., Lopez K; Author Employee of Nicox Ophthalmics, Nicox Ophthalmics, Inc. 4819 Emperor Blvd. Suite 400 Durham, NC 27703, United States., Hubatsch D; Author Employee of Nicox Ophthalmics, Nicox Ophthalmics, Inc. 4819 Emperor Blvd. Suite 400 Durham, NC 27703, United States.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Dec; Vol. 147, pp. 107730. Date of Electronic Publication: 2024 Oct 28.
DOI: 10.1016/j.cct.2024.107730
Abstrakt: Purpose: To identify the optimal dose of NCX 470, a nitric oxide (NO)-donating bimatoprost, for comparison to latanoprost in a phase 3 trial for open-angle glaucoma (OAG) or ocular hypertension (OHTN) using an adaptive dose selection design.
Patients and Methods: In this prospective, multicenter trial, subjects were randomized 1:1:1 to NCX 470 0.065 %, NCX 470 0.1 %, or latanoprost 0.005 % dosed topically to both eyes once daily. After at least 30 subjects were assigned to each group, interim analysis was undertaken at 2 weeks and an independent committee selected the final NCX 470 dose for the full 12-week trial.
Results: The interim analysis included 103 subjects. The least-squares mean (95 % confidence interval [CI]) difference in diurnal intraocular pressure (IOP) was -1.51 mmHg (-2.88, -0.14) in the NCX 470 0.065 % group (p = 0.0308) and - 1.71 mmHg (-3.04, -0.38) in the NCX 470 0.1 % group (p = 0.0123), both favoring NCX 470 over latanoprost. The most common side effect was conjunctival/ocular hyperemia, the frequency and severity of which were similar in both NCX 470 dosing groups (p > 0.05). NCX 470 0.1 % was selected as the final dose and the NCX 470 0.065 % dose arm was terminated with subsequent subjects randomized 1:1 to NCX 470 0.1 % or latanoprost.
Conclusion: Both concentrations of the NO-donating bimatoprost NCX 470 lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SL Mansberger: consultant and stock. R Fechtner: consultant and stock. K Lopez: Employee. D Hubatsch: Employee.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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