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

NCT03192826 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 8393 / 26- 4- 2016
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Capsule Opacification; Ocular Hypertension

Keywords

Nd-YAG capsulotomy; ocular hypertension; brimonidine; brinzolamide

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Brinzolamide/Brimonidine FC

ACTIVE COMPARATOR

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Drug: Brinzolamide/Brimonidine FC

Brimonidine 0.2%

ACTIVE COMPARATOR

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

Drug: Brimonidine 0.2%

Artificial tears

PLACEBO COMPARATOR

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

Drug: Artificial tears

Interventions

Brinzolamide/Brimonidine FC DRUG

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Also known as: SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd

Brinzolamide/Brimonidine FC

Brimonidine 0.2% DRUG

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

Also known as: ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd

Brimonidine 0.2%

Artificial tears DRUG

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

Also known as: TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd

Artificial tears

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

MeSH Terms

Conditions

Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Limitations and Caveats

Corneal thickness was not assessed. The measurement of IOP at more time points could have provided more information regarding the effect of BBFC. We could enroll a larger group of patients in order to provide more strength in our analysis

Results Point of Contact

• Title: OPHTHALMOLOGY PATRAS
• Organization: Patras Medical School

cgeorg@upatras.gr

6975801961

Study Officials

• Constantinos Georgakopoulos, MD, PhD

  University Hospital of Patras

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor of Ophthalmology, Univerisity of Patras

Model Details: This is a prospective, randomized, double masked comparative study

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 20, 2017
• Study Start: June 20, 2016
• Primary Completion: July 8, 2017
• Study Completion: July 8, 2017
• Last Updated: July 16, 2019
• Results First Posted: July 16, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)