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Fixed-dose combination of AR-13324 and latanoprost : a double-masked , 28-day , randomised , controlled study in patients with open-angle glaucoma or ocular hypertension . BACKGROUND/AIMS To evaluate the ocular hypotensive efficacy of fixed-dose combinations of the Rho kinase inhibitor and norepinephrine transport inhibitor AR-13324 ( 0.01 % and 0.02 % ) and latanoprost ( PG324 Ophthalmic Solution ) relative to the active components AR-13324 0.02 % and latanoprost 0.005 % , used bilaterally at night . METHODS This was a double-masked , randomised , parallel comparison study in patients with open-angle glaucoma or ocular hypertension . After washout , patients were randomised to one of four treatment arms and treated for 28 days . The primary efficacy variable was mean diurnal intraocular pressure ( IOP ) at day 29 . RESULTS We randomised 298 patients , of whom 292 ( 98 % ) completed the study . Mean unmedicated diurnal IOPs ( study eye ) was 25.1 , 25.1 , 26.0 and 25.4 in the PG324 0.01 % , PG324 0.02 % , latanoprost and AR-13324 0.02 % groups , respectively . On day 29 , mean diurnal IOP decreased to 17.3 , 16.5 , 18.4 and 19.1 mm Hg , respectively . For the primary efficacy variable of mean diurnal IOP at day 29 , PG324 0.02 % met the criterion for statistical superiority relative to both latanoprost and AR-13324 0.02 % ( p < 0.0001 ) , providing additional IOP lowering of 1.9 and 2.6 mm Hg , respectively . PG324 0.01 % also met the criterion for superiority . The most frequently reported adverse event was conjunctival hyperaemia with an incidence of 41 % ( 30/73 ) , 40 % ( 29/73 ) , 14 % ( 10/73 ) and 40 % ( 31/78 ) in the PG324 0.01 % , PG324 0.02 % , latanoprost and AR-13324 0.02 % groups , respectively . CONCLUSIONS In this short-term study , the fixed-dose combination of AR-13324 0.02 % and latanoprost 0.005 % in PG324 Ophthalmic Solution provides clinically and statistically superior ocular hypotensive efficacy relative to its individual active components at the same concentrations . The only safety finding of note was transient asymptomatic conjunctival hyperaemia which was typically of mild severity . TRIAL REGISTRATION NUMBER NCT02207491 .
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Intervention_Pharmacological
AR-13324 and latanoprost
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Intervention_Pharmacological
AR-13324
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Intervention_Pharmacological
latanoprost
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Intervention_Pharmacological
AR-13324
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Outcome_Other
efficacy
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Outcome_Physical
Mean unmedicated diurnal IOPs
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Outcome_Physical
mean diurnal IOP
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Outcome_Physical
mean diurnal
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Outcome_Adverse-effects
conjunctival hyperaemia
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Participant_Condition
patients with open-angle glaucoma or ocular hypertension .
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Participant_Condition
patients with open-angle glaucoma or ocular hypertension .
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Participant_Sample-size
298 patients
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Participant_Sample-size
292