Double-Masked Randomized Controlled Study of Fixed-Dose Combination Drugs in Patients With Elevated IOP
To evaluate the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution (a fixed dose of latanoprost 0.005% and either 0.01% or 0.02% AR-13324) relative to the active components AR-13324 Ophthalmic Solution, 0.02% or Latanoprost Ophthalmic Solution 0.005%, q.d., PM, O.U.
This was a multicenter, double-masked, randomized parallel group study in which 298 patients with ocular hypertension or open-angle glaucoma with unmedicated IOP ≥ 24 mm Hg at 08:00 hours were randomized to one of four treatments. Patients were dosed and followed for 28 days.
Mean unmedicated diurnal IOP (average of all measurements on Day 1, prior to study medication) 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. PG324 0.02% met the criterion for statistical superiority relative to both latanoprost and AR-13324 0.02% (p < 0.0001) in mean diurnal IOP at Day 29. The most frequently reported adverse event was conjunctival hyperemia with an incidence of 41% (30/73), 40% (29/73), 14% (10/73) and 40% (31/78), respectively.
The fixed-dose combination of AR-13324 0.02% and latanoprost 0.005% in PG324 Ophthalmic Solution provided clinically and statistically superior ocular hypotensive efficacy relative to its individual active components. The only safety finding of note was transient conjunctival hyperemia, which was typically of trace or mild severity.
Walters, Levy, Ramirez, Kopczynski and Novack FOR the PG324-CS201 Study Group