search
Back to results

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

Primary Purpose

Posterior Capsule Opacification, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Brinzolamide/Brimonidine FC
Brimonidine 0.2%
Artificial tears
Sponsored by
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posterior Capsule Opacification focused on measuring Nd-YAG capsulotomy, ocular hypertension, brimonidine, brinzolamide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Patras

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Brinzolamide/Brimonidine FC

Brimonidine 0.2%

Artificial tears

Arm Description

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

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

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2017
Last Updated
June 23, 2019
Sponsor
University Hospital of Patras
search

1. Study Identification

Unique Protocol Identification Number
NCT03192826
Brief Title
Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
July 8, 2017 (Actual)
Study Completion Date
July 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Capsule Opacification, Ocular Hypertension
Keywords
Nd-YAG capsulotomy, ocular hypertension, brimonidine, brinzolamide

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, randomized, double masked comparative study
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brinzolamide/Brimonidine FC
Arm Type
Active Comparator
Arm Description
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Arm Title
Brimonidine 0.2%
Arm Type
Active Comparator
Arm Description
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Arm Title
Artificial tears
Arm Type
Placebo Comparator
Arm Description
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intervention Type
Drug
Intervention Name(s)
Brinzolamide/Brimonidine FC
Other Intervention Name(s)
SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd
Intervention Description
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Intervention Type
Drug
Intervention Name(s)
Brimonidine 0.2%
Other Intervention Name(s)
ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd
Intervention Description
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Intervention Type
Drug
Intervention Name(s)
Artificial tears
Other Intervention Name(s)
TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd
Intervention Description
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
Description
Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time Frame
1 hour
Title
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy
Description
Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time Frame
3 hours
Title
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
Description
Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time Frame
24 hours
Title
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
Description
Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time Frame
1 week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantinos Georgakopoulos, MD, PhD
Organizational Affiliation
University Hospital of Patras
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Patras
City
Patra
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

We'll reach out to this number within 24 hrs