Conditions: Primary Open Angle Glaucoma Ocular Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 379
Healthy volunteers: no

Brief summary:
Primary objective:

The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.

The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

Detailed description:

Arms:
arm 1: 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. arm 2: 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months. arm 3: 1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.

Interventions: intervention 1: Monoprost intervention 2: Lumigan 0.01% intervention 3: Lumigan 0.03% Unit Dose
Intervention descriptions: intervention 1: 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. intervention 2: Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container. intervention 3: Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.

Protocol document: