NCT03192826

Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy

Study of the Efficacy of Brinzolamide 1% Plus Brimonidine 0.2% Versus Brimonidine 0.2% in the Prevention of Intraocular Pressure Rise After Nd-YAG Laser Capsulotomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: University Hospital of Patras · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium: yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.

Detailed description

In this prospective, randomized, double masked clinical trial, patients scheduled to undergo Nd:YAG laser posterior capsulotomy for posterior capsule opacification are randomized in 3 groups. The Brimonidine group receives 1 drop of Brimonidine 0.2%. The Brinzolamide/Brimonidine group receives 1 drop of Brinzolamide 1%/Brimonidine 0.2% fixed combination. The Control group receives artificial tears. All groups are administered a single drop instillation, approximately one hour before Nd:YAG application. Intraocular pressure measurements are performed before treatment (baseline) and at the 1, 3, 24 hours and 1 week post treatment. Dexamethasone ophthalmic drops are prescribed q.i.d. for one week after the procedure.

Conditions

• Posterior Capsule Opacification
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Brinzolamide/Brimonidine FC	1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
DRUG	Brimonidine 0.2%	1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
DRUG	Artificial tears	1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Timeline

• Start date: 2016-06-20
• Primary completion: 2017-07-08
• Completion: 2017-07-08
• First posted: 2017-06-20
• Last updated: 2019-07-16
• Results posted: 2019-07-16

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study