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

Phase 4

Completed

• Conditions: Posterior Capsule Opacification; Ocular Hypertension
• Interventions: Drug: Brinzolamide/Brimonidine FC; Drug: Brimonidine 0.2%; Drug: Artificial tears

• Registration Number: NCT03192826
• Lead Sponsor: University Hospital of Patras

Brief 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.

Study Timeline

• Study Start: 2016-06-20
• Study First Submitted: 2017-06-18
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Primary Completion: 2017-07-08
• Study Completion: 2017-07-08
• Results First Submitted: 2019-04-16
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-23
• Last Update Submitted: 2019-06-23
• Results First Posted: 2019-07-16
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

• patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (PCO) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (IOL/PC).

Exclusion Criteria

• baseline IOP greater than 21mmHg
• glaucomatous eyes, already under treatment with anti glaucomatic medications
• intraocular surgery except for uncomplicated cataract surgery
• previous photorefractive surgery
• active ocular inflammation or infection
• patients under systemic administration of medications known to affect IOP
• patients with severe respiratory or cardiovascular disease
• pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested
• a measurement of IOP > 30 mmHg at any time point of the study, or an increase from baseline >20 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brinzolamide/Brimonidine FC	Brinzolamide/Brimonidine FC	1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Brimonidine 0.2%	Brimonidine 0.2%	1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Artificial tears	Artificial tears	1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy	1 hour	Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy	3 hours	Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy	24 hours	Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy	1 week	Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patra, Achaia, Greece