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

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ClinicalTrials.gov Identifier: NCT03192826
Recruitment Status : Completed
First Posted : June 20, 2017
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Constantinos D. Georgakopoulos, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Posterior Capsule Opacification Ocular Hypertension Drug: Brinzolamide/Brimonidine FC Drug: Brimonidine 0.2% Drug: Artificial tears Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomized, double masked comparative study
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Prevention
Official 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
Actual Study Start Date : June 20, 2016
Actual Primary Completion Date : July 8, 2017
Actual Study Completion Date : July 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Brinzolamide/Brimonidine FC
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Drug: Brinzolamide/Brimonidine FC
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Other Name: SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd

Active Comparator: Brimonidine 0.2%
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Drug: Brimonidine 0.2%
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Other Name: ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd

Placebo Comparator: Artificial tears
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Drug: Artificial tears
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Other Name: TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd




Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192826


Locations
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Greece
University Hospital of Patras
Patra, Achaia, Greece, 26504
Sponsors and Collaborators
University Hospital of Patras
Investigators
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Study Director: Constantinos Georgakopoulos, MD, PhD University Hospital of Patras
  Study Documents (Full-Text)

Documents provided by Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras:

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Responsible Party: Constantinos D. Georgakopoulos, MD, PhD, MD, PhD, Associate Professor of Ophthalmology, Univerisity of Patras, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT03192826     History of Changes
Other Study ID Numbers: 8393 / 26- 4- 2016
First Posted: June 20, 2017    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras:
Nd-YAG capsulotomy
ocular hypertension
brimonidine
brinzolamide
Additional relevant MeSH terms:
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Brimonidine Tartrate
Ocular Hypertension
Capsule Opacification
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Cataract
Lens Diseases
Lubricant Eye Drops
Brinzolamide
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Ophthalmic Solutions
Pharmaceutical Solutions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors