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 2

Final formula for dorzolamide 2% eye drops solution.

No.	Material	Amount	Function
1	Dorzolamide hydrochloride (corresponding to dorzolamide)	22.30 mg (20.0 mg)	Active substance
2	Hydroxyethyl cellulose	1.00 mg	Viscosity-increasing agent
3	Citric acid monohydrate	4.00 mg	Buffering agent
4	Sodium hydroxide	2.26 mg	Buffering agent
5	Mannitol	20.00 mg	Tonicity agent
6	Benzalkonium chloride	0.075 mg	Antimicrobial preservative
7	Purified water	1.0 mL	Vehicle

For the innovator formula, no details are published and available.