Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose

PHASE4CompletedINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Primary Open Angle GlaucomaOcular Hypertension
Interventions
DRUG

Monoprost

Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.

DRUG

Lumigan 0.01%

Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.

DRUG

Lumigan 0.03% Unit Dose

Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.

Trial Locations (1)

63000

Laboratoires Théa, Clermont-Ferrand

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Laboratoires Thea

INDUSTRY