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Xalatan Delivery Device Comparison in Glaucoma

NCT00283764Phase 3

Key facts

Status: Withdrawn
Sponsor: Viatris
Modality: Orthosteric Ligands

Drugs: latanoprost
Conditions: Open-angle glaucoma (OAG)ocular hypertension

Overview

Phase 3, randomised, open-label trial of latanoprost in Open-angle glaucoma (OAG) and ocular hypertension (2 arms), sponsored by Viatris. Primary endpoint: Intraocular Pressure at 12 weeks. Status: withdrawn.

Design

2 arms

Study design: RandomizedOpen-label

Conventional Dropper Bottle
Standard delivery method for Xalatan eyedrops.
Forced-Flow Delivery Device
Experimental delivery device for Xalatan eyedrops.

Who it enrols

Adults with primary open-angle glaucoma or ocular hypertension in one or both eyes, excluding those with a history of closed or barely open anterior chamber angles.

Endpoints

Primary

Intraocular Pressure12 weeks

Secondary

Successful eyedrop self-deliveries12 weeks
Ease of eyedrop administration12 weeks
Change in safety assessments12 weeks
Subject preference for the method of drop delivery12 weeks

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