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EFFICACY

COMPARISON OF THE EFFICACY AND TOLERABILITY OF

PRESERVATIVE-FREE AND PRESERVATIVE-CONTAINING

FORMULATIONS OF THE DORZOLAMIDE/TIMOLOL FIXED
COMBINATION (COSOPT™) IN PATIENTS WITH ELEVATED

INTRAOCULAR PRESSURE IN A RANDOMIZED CLINICAL TRIAL

Shedden A, et al. Graefes Arch Clin Exp Ophthalmol. 2010 Dec;248(12):1757-64.

ABSTRACT

PURPOSE: This study compare the efficacy and tolerability of PF and P-containing formulations of the
DTFC COSOPT™ in patients with elevated IOP.

METHODS: Parallel, randomized, double-masked study was conducted in 261 patients.
After a 3-week run-in on timolol, patients with an IOP ≥22 mmHg were randomized 1:1 to receive pre-
servative free (PF) or preservative containing (PC) dorzolamide/timolol twice daily for 12 weeks.

STUDY CRITERIA:
X Efficacy
X Safety and tolerance criteria: Ocular symptoms, signs, and adverse experiences
were recorded at each visit.

RESULTS: In the PF group 26.7% (35/131) of patients had adverse events, vs in the PC group 33.8%
(44/130) (P > 0,005).
The most common adverse events were ocular burning/stinging: 16.0% of patients in the PF group vs
21.5% in the PC group.

Taste perversion: 3.1% of patients in the PF group vs 5.4% in the PC group.

Type PF dorzolamide/timolol (N=130) PC dorzolamide/timolol (N=131)
Any adverse event 35 (26.7) 44 (33.8)
Drug-related adverse event 27 (20.6) 35 (26.9)
Serious adverse event 2 (1.5) 0 (0.0)
Discontinued due to adverse event 4 (3.1) 3 (2.3)
Common adverse events
Occular burning/stinging 21 (16.0) 28 (21.5)
Taste perversion 4 (3.1) 7 (5.4)

Table 5 Events with PF and PC dorzolamide/timolol
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