At baseline, when all patients were receiving beta-blocker alone, there was no statistical difference between the treatment groups.
The IOP (mean +/- SD mmHg) at baseline was 20.9 (+/- 4.9) for the latanoprost monotherapy group, 20.9 (+/- 4.3) for the latanoprost plus beta-blocker group, and 21.7 (+/- 6.3) for the brimonidine plus beta-blocker group, (p=0.71).
The IOP (mean +/- SD) at last on-study-treatment visit (final follow-up visit) was 18.0 +/- 3.0 (18.0 +/- 2.9) for the latanoprost monotherapy group, 16.5 +/- 3.8 (16.4 +/- 4.0) for the latanoprost plus beta-blocker group, and 17.8 +/- 4.4 (17.1 +/- 4.1) for the brimonidine plus beta-blocker group, (p=0.078 (p=0.076)).
The IOP change (mean +/- SD) from baseline to last on-study-treatment visit (final follow-up visit) was 2.9 +/- 5.1 (2.8 +/- 4.6) for the latanoprost monotherapy group, 4.4 +/- 5.1 (4.5 +/- 5.5) for the latanoprost plus beta-blocker group, and 3.9 +/- 5.5 (4.6 +/- 5.2) for the brimonidine plus beta-blocker group, (p=0.38 (p=0.23)).
The number of medicine changes per person per month (mean +/- SD) were 0.01 (+/- 0.03l) for the latanoprost monotherapy group, 0.01 (+/- 0.06) for the latanoprost plus beta-blocker group, and 0.04 (+/- 0.06) for the brimonidine plus beta-blocker group, (p=0.001).
The number of visits per person per month (mean +/- SD) was 0.36 (+/- 0.20) for the latanoprost monotherapy group, 0.38 (+/- 0.20) for the latanoprost plus beta-blocker group, and 0.46 (+/- 0.22) for the brimonidine plus beta-blocker group, (p=0.05).
The total number of visits (mean +/- SD) was 3.8 (+/- 2.0) for the latanoprost monotherapy group, 4.2 (+/- 1.5) for the latanoprost plus beta-blocker group, and 4.5 (+/- 2.0) for the brimonidine plus beta-blocker group, (p=0.16).
Adverse events are detailed below,
There were 10 (27%) incidents of blurred vision in the latanoprost monotherapy group, 15 (20%) in the latanoprost plus beta-blocker group, and 12 (32%) in the brimonidine plus beta-blocker group, (p=0.62).
There were 4 (11%) incidents of allergy in the latanoprost monotherapy group, 16 (22%) in the latanoprost plus beta-blocker group, and 8 (22%) in the brimonidine plus beta-blocker group, (p=0.35).
There were 5 (14%) incidents of tearing or watering in the latanoprost monotherapy group, 9 (12%) in the latanoprost plus beta-blocker group, and 12 (32%) in the brimonidine plus beta-blocker group, (p=0.27).
There were 4 (11%) incidents of conjunctival hyperemia in the latanoprost monotherapy group, 10 (14%) in the latanoprost plus beta-blocker group, and 3(8%) in the brimonidine plus beta-blocker group, (p=0.69).
There were 3 (8%) incidents of burning or stinging in the latanoprost monotherapy group, 2 (3%) in the latanoprost plus beta-blocker group, and 5 (14%) in the brimonidine plus beta-blocker group, (p=0.095).
There were 3 (8%) incidents of mucus or runny discharge in the latanoprost monotherapy group, 2 (3%) in the latanoprost plus beta-blocker group, and 4 (11%) in the brimonidine plus beta-blocker group, (p=0.20).
There was 1 (3%) incident of blepharitis in the latanoprost monotherapy group, 5 (7%) in the latanoprost plus beta-blocker group, and 2 (5%) in the brimonidine plus beta-blocker group, (p=0.67).
There were 2 (5%) incidents of ocular pain in the latanoprost monotherapy group, 3 (4%) in the latanoprost plus beta-blocker group, and 3 (8%) in the brimonidine plus beta-blocker group, (p=0.67).
The number of incidents of foreign body sensation was "not reported" for the latanoprost monotherapy group, 5 (7%) for the latanoprost plus beta-blocker group, and 2 (5%) for the brimonidine plus beta-blocker group, (p=0.28).
There were 3 (8%) incidents of dryness in the latanoprost monotherapy group, 1 (1%) in the latanoprost plus beta-blocker group, and 1 (3%) in the brimonidine plus beta-blocker group, (p=0.17).
The number of incidents of irritated lids was 1 (3%) in the latanoprost monotherapy group, 2 (3%) in the latanoprost plus beta-blocker group, and "not reported" for the brimonidine plus beta-blocker group, (p=0.60).
The total number of adverse events was 36 for the latanoprost monotherapy group, 70 for the latanoprost plus beta-blocker group, and 52 for the brimonidine plus beta-blocker group.
The total number of patients having adverse events was 21 (57%) for the latanoprost monotherapy group, 41 (55%) for the latanoprost plus beta-blocker group, and 22 (59%) for the brimonidine plus beta-blocker group, (p=0.79).