PRIMARY THERAPY STUDIES WITH BRINZOLAMIDE

J. Thygesen and The Brinozolamide Study Group

Department of Ophthalmology 2061, Rigshospitalet, University of Copenhagen, Denmark

Brinzolamide Primary Therapy Study No. 1.

Methods: A double-masked, randomized,parallel, placebo-controlled multicenter study of brinzolamide 1.0%  (b.i.d and t.i.d.) and dorzolamide 2.0% (t.i.d.) in 463 patients for a 3-month treatment period.

Efficacy Results: Mean peak IOP reduction at Month 3: brinzolamide b.i.d.: 16.0 % (4.0 mm Hg). brinzolamide t.i.d.: 18.0% (4.6 mmHg). dorzolamide t.i.d.: 18.7% (4.6 mmHg).

Conclusion: Brinzolamide t.i.d. is equivalent to dorzolamide t.i.d. in peak IOP reduction in a 3-month  treatment period.

Brinzolamide Primary Therapy Study No. 2.

Methods: Double-masked, randomized, parallel, active-controlled multicenter  study of brinzolamide 1.0% b.i.d., brinzolamide 1.0% t.i.d., dorzolamide 2.0% t.i.d. and timolol 0.5% b.i.d. for a 3 month treatment period with 572 patients.

Efficacy Results: Mean peak IOP reduction at Month 3: brinzolamide b.i.d.: 19.5% (5.1 mmHg); brinzolamide t.i.d.: 20.0% (5.2 mmHg); timolol b.i.d.: 22.5% (5.9 mmHg). 

Conclusion: Brinzolamide b.i.d. is equivalent to brinzolamide t.i.d. in peak IOP reduction in a 3 month  treatment period.

Brinzolamide Long-Term Therapy Study. 

Methods: Double-masked, randomized, parallel, active-controlled multicenter study of brinzolamide 1.0% b.i.d. and t.i.d. and timolol 0.5% b.i.d. for an 18 month treatment period in 379 patients.

Efficacy Results: Mean IOP reductions at trough over 18 months:brinzolamide b.i.d.: 3.3 mmHg; brinzolamide t.i.d.: 3.3 mmHg.

Conclusion: Brinzolamide b.i.d. is equivalent to brinzolamide t.i.d. in IOP reduction at trough over 18 month. 

Overall Conclusion: Brinzolamide t.i.d. is equivalent to brinzolamide b.i.d and dorzolamide 2.0% t.i.d. as  primary therapy for patients with OAG or OH.