A Randomized, Double-Masked, Active-Controlled, Crossover Phase III Equivalence Study of Generic Dorzolamide 2% versus Innovator Trusopt® Eye Drop Solution in Subjects with Open-Angle Glaucoma or Ocular Hypertension

Table 4

Summary statistics for the average IOP in the study eye.

Variable	Statistics	T	R	T-R
Baseline IOPav (mmHg)	N	32	32	32
	Mean	20.01	20.35	−0.34
	Standard deviation	3.04	3.11	2.51
	Min	14.67	16.00	−6.33
	Median	19.67	19.58	0.00
	Max	27.33	27.50	5.33
IOPav (mmHg)	Mean	17.83	17.65	0.19
	Standard deviation	3.55	2.82	3.03
	Min	13.67	13.00	−5.00
	Median	17.33	17.83	0.58
	Max	28.00	24.00	9.50
δIOPav (mmHg)	Mean	2.18	2.70	−0.52
	Standard deviation	2.36	2.76	3.45
	Min	−2.67	−2.67	−8.83
	Median	2.33	3.00	−0.08
	Max	6.67	8.50	4.83

The signs of the baseline-corrected effects are positive (the larger the desired effect, the larger the value). The negative T-R δIOPav indicates a higher average IOP reduction of 0.52 mmHG for the reference/original product. T, test product; R, reference product.