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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Posterior Capsule Opacification, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide/Brimonidine FC
* Drug: Brimonidine 0.2%
* Drug: Artificial tears


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, randomized, double masked comparative study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brinzolamide/Brimonidine FC<br>1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy | Drug: Brinzolamide/Brimonidine FC<br>* 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy<br>* Other names: SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd;|
| Active Comparator: Brimonidine 0.2%<br>1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy | Drug: Brimonidine 0.2%<br>* 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy<br>* Other names: ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd;|
| Placebo Comparator: Artificial tears<br>1 drop of artificial tears 1 hour before Nd-YAG capsulotomy | Drug: Artificial tears<br>* 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy<br>* Other names: TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nd-YAG capsulotomy, ocular hypertension, brimonidine, brinzolamide