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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 8, 2017

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Brinzolamide/Brimonidine FC
    • 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
  • Active Comparator: Brimonidine 0.2%
    • 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
  • Placebo Comparator: Artificial tears
    • 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 1 week
    • Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital of Patras
  • Provider of Information About this Clinical Study
    • Principal Investigator: Constantinos D. Georgakopoulos, MD, PhD, MD, PhD, Associate Professor of Ophthalmology, Univerisity of Patras – University Hospital of Patras
  • Overall Official(s)
    • Constantinos Georgakopoulos, MD, PhD, Study Director, University Hospital of Patras

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