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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
379
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.
Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
Laboratoires Théa
Clermont-Ferrand, France
Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye
The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit. The conjunctival hyperaemia will be scored using the "McMonnies" photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia. The Rows represent the number of participants with a change from Baseline to D84 corresponding to * "decrease of 3 points" * "decrease of 2 points" * "no change", * "increase of 2 points" * "increase of 1 point" on Mc Monnies scale
Time frame: Day 84
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