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SAFETY AND EFFICACY

RANDOMIZED TRIAL COMPARING THE DORZOLAMIDE-

TIMOLOL COMBINATION GIVEN TWICE DAILY TO

MONOTHERAPY WITH TIMOLOL AND DORZOLAMIDE

Boyle JE, et al. Ophthalmology. 1998 Oct;105(10):1945-51.

ABSTRACT

PURPOSE: To compare the efficacy and safety of a fixed combination of 2.0% dorzolamide and 0.5%
timolol administered twice daily with each of the individual components administered in their usual
monotherapy dose regimens in patients who had washed out all ocular hypotensive medications.
METHODS : A 3-month, parallel, randomized, double-masked, active-controlled, multicenter clinical
trial with a total of 335 patients with bilateral ocular hypertension or OAG (Dorzolamide/Timolol = 114;
Dorzolamide = 109; Timolol = 112) . After completing a washout of ocular hypotensive medications,
patients were randomized to receive either the dorzolamide-timolol combination twice daily plus
placebo once daily, 0.5% timolol twice daily plus placebo once daily, or 2.0% dorzolamide three times
daily.

STUDY CRITERIA: IOP (mmHg)

RESULTS: At morning trough, the percent mean IOP reduction from baseline was:
X 27.4% (-7.7mmHg) in the combination group

X 15.5% (-4.6mmHg) in the Dorzolamide group
X 22.2% (-6.4mmHg) in the Timolol group
X At morning peak, the mean IOP reduction from baseline was:
X 32.7% (-9.0mmHg) in the combination group

X 19.8% (-5.4mmHg) in the Dorzolamide group
X 22.6% (-6.3mmHg) in the Timolol group

Figure 4: Mean IOP at morning trough

CONCLUSIONS: The IOP-lowering effect of the Dorzolamide-Timolol fixed combination is greater
than that of either Dorzolamide or Timolol administered as monotherapy.
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