H-1337 Ophthalmic Solution Phase 1/2

Status Completed

Clinical Trial Summary

The study will evaluate the safety, tolerability, and preliminary efficacy of three concentrations of H-1337 and vehicle administered twice daily in a parallel group, double-masked design for 28 days of dosing in patients with elevated intraocular pressure (IOP).

Clinical Trial Description

Study ALY337-201 will be a double-masked, randomized, placebo-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of H-1337 ophthalmic solution in subjects with ocular hypertension (OHT) or open angle glaucoma. During screening, subjects who meet the preliminary inclusion/exclusion criteria will discontinue use of their ocular hypotensive therapy during the washout period. The washout duration will be dependent on the subject's pre-study ocular hypotensive therapy. Starting on Day 0, those who continue to meet the inclusions/exclusion criteria and the diurnal IOP criteria will be randomized into one of the treatments arms and dosing will be initiated, continuing for 28 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03452033
Study type	Interventional
Source	Allysta Pharmaceutical
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	March 15, 2018
Completion date	August 15, 2018

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