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 1

Inclusion and exclusion criteria.

Inclusion criteria
Age >18 years	Male/female, all races
Primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, and ocular hypertension	In one or both the eyes
Baseline IOP after washout (study eye)	IOP between 18 and 32 mmHg in one of the 3 measurements (in the eyes not included in the study (fellow eye); IOP must have been controllable on no pharmacologic treatment or on the study medicine only)
Best-corrected distance visual acuity	20/200 (Snellen equivalent) or better in the study eye
Exclusion criteria
Patients presenting one of the following criteria were excluded from study enrollment.
Chronic or recurrent inflammatory eye disease
Ocular trauma within the past six months
Current ocular infection, i.e., conjunctivitis or keratitis
Any abnormality preventing reliable applanation tonometry
Intraocular surgery or laser treatment within the past three months
Inability to discontinue contact lens wear during the study
Use of any systemic medication that would affect IOP with less than a 1-month stable dosing regimen before the screening visit
Patient allergic to sulfonamides
Severe renal dysfunction or hyperchloraemic acidosis