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EFFICACY

Boyle et al Dorzolamide–Timolol Component Comparison in Washed-out Patients

Table 3. Estimated Differences, Confidence Intervals, and P Values for Difference between Treatments in Mean Percent Change in
Intraocular Pressure (IOP) from Baseline*
Combination Dorzolamide† Combination Timolol†
Percentage Percentage
Point Point
Examination Difference‡ 95% CI P Difference‡ 95% CI P
Hr 0
Wk 2 12.4 15.6, 9.1 0.001 5.9 9.2, 2.7 0.001
Mo 1 11.0 14.0, 8.1 0.001 3.4 6.3, 0.5 0.024
Mo 2 11.5 14.6, 8.3 0.001 4.0 7.1, 0.9 0.011
Mo 3 12.0 15.3, 8.7 0.001 4.9 8.2, 1.6 0.003
Hr 2
Wk 2 11.3 14.4, 8.1 0.001 8.1 11.2, 5.0 0.001
Mo 1 11.7 15.0, 8.5 0.001 8.5 11.8, 5.3 0.001
Mo 2 12.7 16.2, 9.2 0.001 10.5 14.0, 7.1 0.001
Mo 3 12.9 16.4, 9.4 0.001 9.9 13.4, 6.4 0.001
CI confidence interval.
* All patients treated analysis (last observation carried forward) worse eye.
† (Percent change in IOP with combination) (percent change in IOP with component).
‡ Negative values for the percentage point differences favor the combination.

63 while receiving dorzolamide, and 53 while receiving timolol. adverse experience in all three treatment groups was burning
There were no statistically significant differences between the and/or stinging eye, only one patient, who was receiving the
combination group and its components in the proportion of pa- combination, discontinued from the study because of burning and
tients with any adverse experience, with drug-related adverse stinging. The next most frequent adverse experience was taste
experiences, or with serious adverse experiences. A significantly perversion, which was reported by significantly more patients
greater proportion of patients discontinued from the study due to receiving the combination than timolol (8% vs. 1%, P 0.019).
adverse experiences in the combination group than in the timolol The most common nonocular clinical adverse experiences other
group (7% vs. 1%, P 0.035). Of the eight patients who discon- than taste perversion reported during the study were upper respi-
tinued while receiving the combination, five discontinued because ratory infection and headache, which occurred in generally the
of drug-related adverse experiences. Three of these five patients same frequency in all treatment groups.
discontinued because of ocular adverse experiences including oc- Table6 displays the ocular symptoms reported by at least 1%
ular swelling, follicular conjunctivitis, foreign body sensation, of the patients in any treatment group. The most commonly re-
cloudy vision, burning and/or stinging, photosensitivity, and eye ported ocular symptoms in all three groups were blurred vision,
pain. The other two patients receiving the combination who dis- stinging eye, and burning eye. There were no significant differ-
continued because of drug-related adverse experiences reported
nausea, dyspepsia, anorexia, tinnitus, and nasal congestion. The
one patient receiving timolol who discontinued did so because of
a nonocular, nondrug-related adverse experience. Table 5. Ocular and Local Adverse Experiences (Incidence
The most frequent adverse experience was ocular or local in 2% in Any Treatment Group)*
nature. Table5 presents the number of patients with ocular and
local adverse experiences that occurred in more than 2% of pa- Combination Dorzolamide Timolol
tients in any treatment group. Although the most common ocular Adverse Experience (N 114) (N 109) (N 112)
Patients with any special
senses AE 38 (33) 39 (36) 24 (21)
Blurred vision 5 (4) 4 (4) 5 (4)
Table 4. Adverse Experience Summary: No. (%) of Patients Burning/stinging, eye† 21 (18) 15 (14) 7 (6)
Discharge, eye 1 (1) 1 (1) 4 (4)
Combination Dorzolamide Timolol Foreign body sensation 2 (2) 3 (3) 1 (1)
Injection, ocular 3 (3) 4 (4) 1 (1)
Patients evaluated 114 109 112 Itching, eye 4 (4) 3 (3) 0
With any adverse experience 57 (50) 63 (58) 53 (47) Perversion, taste‡ 9 (8) 11 (10) 1 (1)
Without any adverse experience 57 (50) 46 (42) 59 (53) Tearing 3 (3) 3 (3) 1 (1)
Serious adverse experience 3 (3) 2 (2) 1 (1)
Withdrawn due to adverse
experience* 8 (7) 4 (4) 1 (1) AE adverse experience.
Patients who died 1 (1) 0 0 * If a patient reported a particular adverse experience more than once, the
Drug-related adverse experience† 29 (25) 30 (28) 21 (19) patient was counted only once with that adverse experience. Patients with
more than one clinical adverse experience in a body system are counted
only once in the body system total.
* Combination versus timolol, P 0.035.
† Drug-related implies possibly, probably, or definitely drug-related as † Combination versus timolol, P 0.008.
determined by the investigator. ‡ Combination versus timolol, P 0.019.

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