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Voyager: Latanoprostene Bunod Dose Finding in Glaucoma
NCT01223378Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2010
- Primary completion
- Dec 2011
- Countries
- 1
- Sponsor
- Bausch + Lomb
- Modality
- Small Molecules
- Drugs
- latanoprostene bunod
- Conditions
- open-angle glaucoma (OAG)ocular hypertension
01
Overview
Phase 2, randomised, single-blind trial of latanoprostene bunod in open-angle glaucoma (OAG) and ocular hypertension (5 arms), sponsored by Bausch + Lomb. Primary endpoint: Change in Mean Diurnal Intraocular Pressure at 28 days. Started Dec 2010; status: completed.
02
Design
5 arms- Study design
- RandomizedSingle-blind
LBN 0.006%
Latanoprostene bunod 0.006% QD
LBN 0.012%
Latanoprostene bunod 0.012% QD
LBN 0.024%
Latanoprostene bunod 0.024% QD
LBN 0.040%
Latanoprostene bunod 0.040% QD
Latanoprost 0.005%
Latanoprost 0.005% QD
03
Who it enrols
Adults with open-angle glaucoma or ocular hypertension, IOP between 22-32 mmHg, and no contraindications to latanoprost or nitric oxide.
04
Endpoints
Primary
Change in Mean Diurnal Intraocular Pressure
Secondary
Change in Mean Diurnal Intraocular Pressure at Visits 4, 5, and 7
Proportion of Subjects with IOP <= 18 mmHg
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM)
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