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EFFICACY

Konstas et al 24-Hour IOP-Lowering Effects of Latanoprost and Dorzolamide/Timolol

Table 1. Baseline Demographics Table 5. Adverse Events ( 3)
Criteria Average or No. of Occurrences Adverse Events Latanoprost DTFC P Value
Age (yrs) 61.2 13.3 Stinging/burning 6 30 0.0001
Gender Bitter taste 0 16 0.0002
Male 21 Ocular itching 12 1 0.004
Female 32 Conjunctival hyperemia 9 4 0.1
Baseline intraocular pressure (10 AM) 27.1 2.6 Superficial punctate keratitis 6 7 1.0
Previous therapy ( 2 patients) Dry eye sensation 3 7 0.3
New patient 16 Hypertrichosis 7 0 0.02
DTFC 9 Foreign body sensation 4 3 1.0
LTFC 5 Headaches 6 0 0.04
Latanoprost 5 Hyperchromia of iris 5 0 0.07
Timolol 4 Watering 3 1 0.6
Travoprost 4
Latanoprost and timolol 3
Bimatoprost 2 DTFC dorzolamide/timolol fixed combination.
Corneal pachymetry ( m) 551.0 25.5
Visual acuity 0.9 0.2
Cup-to-disc ratio 0.6 0.1
Mean defect 5.2 4.4 Because of the 8-week interval between the end of treatment
period 1 and the month 2 visit in period 2, we checked for a period
effect for both medicines. The treatment periods were 6-month
DTFC dorzolamide/timolol fixed combination; LTFC latanoprost/
timolol fixed combination. intervals when the patient was treated with a masked study med-
icine, either latanoprost or the DTFC. No significant difference
was found in IOP for either medicine, at the month 2 visit, between
Both treatments reduced the IOP from baseline at each time periods 1 and 2.
point and for the 24-hour curve at month 6 (P 0.03). All patients
had a 15% reduction in pressure on the latanoprost treatment.
When the 2 treatments were compared directly, the primary effi- Adverse Events
cacy variable, mean 24-hour pressure at month 6, did not signifi-
cantly differ between treatments. Further, maximum IOP (P The most frequent ocular and systemic adverse events are shown
0.8), minimum IOP (P 0.5), and range of IOP (P 0.4) between in Table 5. There were 39 adverse events with latanoprost and 51
treatments did not significantly differ between groups. events with the dorzolamide/timolol maleate fixed combination.
In contrast, at month 2 the fixed combination also demonstrated The DTFC group had more burning and stinging (P 0.001) and
a significant decrease compared with latanoprost for the mean bitter taste (P 0.01), whereas the latanoprost group had more
24-hour pressure (P 0.002) and mean maximum (P 0.007) and hypertrichosis (P 0.02), headaches (P 0.04), and ocular
minimum (P 0.004) pressures. itching (P 0.004).
When each study medicine was compared directly between No serious adverse events occurred in this study. Five pa-
months 2 and 6 (Table 4 [available at http://aaojournal.org]), there tients discontinued (3 from the dorzolamide/timolol maleate
was a significantly different reduction in mean pressure for the fixed combination period and 2 from the latanoprost period).
latanoprost group for the diurnal curve and for the maximum and
range, whereas the DTFC showed no significant changes for any The patients were discontinued from the DTFC due to intoler-
ance, dyspnea, and loss to follow-up and from latanoprost due
parameter except a significant decrease in range of pressure (P to hyperemia, watering, and headaches.
0.04).

Figure 1. Twenty-four–hour intraocular pressure levels (millimeters of mercury) at untreated baseline (Œ) and for latanoprost ( ) and the dorzolamide/
timolol fixed combination ( ) after 6 months of treatment.

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