Effect of Fixed Brinzolamide-brimonidine Combination on I... | NCT03494257

Studies
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification

NCT03494257

Sponsor

University Hospital of Patras

Status

Completed

Last Update Posted

Apr 11, 2018Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Cataract
Intraocular Pressure

Interventions

Brinzolamide-Brimonidine fixed combination

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2017Actual

Primary Completion Date

Mar 20, 2018Actual

Completion Date

Apr 6, 2018Actual

First Submitted Date

Apr 2, 2018

First Submission Date that Met QC Criteria

Apr 9, 2018

First Posted Date

Apr 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2018

Last Update Posted Date

Apr 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Constantinos D. Georgakopoulos, MD, PhD, Associate Professor in Ophthalmology, University Hospital of PatrasPrincipal Investigator

Lead Sponsor

University Hospital of PatrasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery.

Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.

The treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination immediately after surgery, and the control group will receive no treatment. The IOP will be measured preoperatively and at 6, 12, and 24 hours postoperatively.

Detailed Description

Phacoemulsification with the use of an ophthalmic viscosurgical device (OVD) and implantation of a foldable intraocular lens (IOL) is the preferred technique for cataract surgery today.

OVDs in spite of their advantages in phacoemulsification surgery, have been correlated with intraocular pressure (IOP) increase within the first 24 hours postoperatively. This constitutes a frequent short-term complication of cataract surgery and can lead to corneal edema and pain. This IOP rise may also increase the risk of retinal artery occlusion, ischemic optic neuropathy, and deterioration of preexisting glaucomatous nerve damage.

DuoVisc, an OVD that consists of Viscoat (chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) in combination with Provisc (sodium hyaluronate 1.0%) is the most frequently used OVD during cataract surgery.

To prevent IOP spikes postoperatively, various antiglaucoma agents have been used. Brinzolamide is a carbonic anhydrase inhibitor that acts upon the ciliary processes and reduces aqueous humor secretion.Brimonidine is a highly selective a2-adrenergic agonist that increases uveoscleral outflow and reduces aqueous humor production.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brinzolamide-Brimonidine fixed combination	Active Comparator	1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery	Drug: Brinzolamide-Brimonidine fixed combination
No topical IOP reducing medication	No Intervention	No IOP reducing drops instilled after surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brinzolamide-Brimonidine fixed combination	Drug	Simbrinza 0.2%-1% Ophthalmic Suspension	Brinzolamide-Brimonidine fixed combination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP at 6 hours after surgery	IOP will be measured by the same Goldman applanation tonometer used preoperatively	6 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
IOP at 12 hours after surgery	IOP will be measured by the same Goldman applanation tonometer used preoperatively	12 hours postoperatively
IOP at 24 hours after surgery	IOP will be measured by the same Goldman applanation tonometer used preoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled to undergo cataract surgery by phacoemulsification.

Exclusion Criteria:

previous ocular surgery
ocular hypertension
pseudoexfoliation syndrome
pigment dispersion syndrome
glaucoma
history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
hypersensitivity to sulfonamides or brimonidine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Constantine Georgakopoulos, MD, PhD	Medical School, University of Patras, Greece	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Patras		Pátrai	Achaia	26504	Greece

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

Masking Description

Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.

Who Masked

ParticipantInvestigator