Results
One patient in the OptiZenm group, whose
onset occurred between the initial workup and
Day 1 of the study drug, was removed from the
study because of an unrelated medical illness.
Median scores and ranges for each of the four
measurement times and 5 days are reported
(see Table 2). The results of this study can be
seen in Tables 3, 4, and 5. Comparisons
between the study drug used, overall total
treatment time (Day 1 compared with Day 5),
day (Day 1 through Day 5), and measurement
time (pretreatment, first dose, second dose,
and end of day) were each evaluated in isolation.
Table 3
Differences between OptiZenTM and VisineB Orig-
inal with respect to alleviating symptoms of ocu-
lar discomfort were not statistically different (P
= 0.55). Over the total treatment time, the odds
of feeling ocular discomfort at the end of the trial
period were 97% less (calculated as 1.00 - 0.032)
than the odds of feeling ocular discomfort at the
beginning of the trial, regardless of the drug used
(P < 0.001).
When days of treatment (Day 1 through Day 5)
were isolated, there was a linear trend in the asso-
ciation of decreased discomfort and the day over-
all, although this finding did not achieve
statistical significance (P = 0.10). Day 5 alone
achieved a significant reduction in the level of dis-
comfort compared with Day 1 (P = 0.05).
When the measurement times for each individual
dose were isolated (first dose, second dose, and
end of day), each measurement time showed a sig-
nificant decrease in the level of ocular discomfort
compared to pre-treatment values (P < 0.001 for
each measurement). For each unit increase in the
four units of measurement time, discomfort level
decreased by 54% (1.00 - 0.46; Pe0.001).
Table 4
A direct comparison of OptiZenTM and VisineB
Original scores each day was also assessed. No
statistically significant difference was seen (P =
0.72) in ocular discomfort between the two drugs,
suggesting that the effect of day on the level of
discomfort does not vary between OptiZen" and
Visine@ Original (see Table 4). Furthermore, OptiZenTM and Visine@ Original were very similar with
respect to odds ratios and 95% CI for each of the
measurement times evaluated. These nearly identical odds ratios did not reach statistical significance (P = 0.72).
Table 5
menty-eight percent of patients (7 of 25) in the
Visinem Original group reported stinginglburning
sensation with medication instillation, while 4%
of patients (1 of 24) in the OptiZen" group
reported stinginglburning sensation with instillation. The chi-square test result shows that the
proportion of patients who experienced sting-
inglburning in the OptiZen" group was statistically significantly lower than those in the
VisineB Original group (Fisher's exact P = 0.05).
Patients using OptiZenTM were 89% less likely to
have stinginglburning effects than those patients using VisineB Original (1.0 - 0.11). No other
adverse events were reported.
The average changes in the weight of the study
bottles were 1.19 grams (k0.54 grams) for
OptiZenTM and 1.32 grams (k0.81 grams) for
VisineB Original, which were not significantly different.