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Completed

NCT Number: NCT03192826

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

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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Key information

Conditions

Posterior Capsule Opacification Eye Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brinzolamide/Brimonidine FC

Drug

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Other names: SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd

Brimonidine 0.2%

Drug

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

Other names: ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd

Artificial Tears

Drug

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

Other names: TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2017
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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