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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-20

Study Completion Date

2017-07-08

Brief Summary

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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.

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Detailed Description

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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

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Posterior Capsule Opacification Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective, randomized, double masked comparative study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Patients are masked to their assignment by covering the labels on the bottles of the drugs administered The investigator responsible for the measurement of the intraocular pressure is also masked to the intervention administered to each patient.

Study Groups

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Brinzolamide/Brimonidine FC

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Group Type ACTIVE_COMPARATOR

Brinzolamide/Brimonidine FC

Intervention Type DRUG

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Brimonidine 0.2%

1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy

Group Type ACTIVE_COMPARATOR

Brimonidine 0.2%

Intervention Type DRUG

1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy

Artificial tears

1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Group Type PLACEBO_COMPARATOR

Artificial tears

Intervention Type DRUG

1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Interventions

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Brinzolamide/Brimonidine FC

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Intervention Type DRUG

Brimonidine 0.2%

1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy

Intervention Type DRUG

Artificial tears

1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Intervention Type DRUG

Other Intervention Names

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SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No