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

NCT03494257 | Completed

• 1 other identifier: 58/15.02.2018/5104
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Intraocular Pressure

Keywords

phacoemulsification; intraocular pressure; cataract; brinzolamide; brimonidinde; fixed combination

Outcome Measures

Primary Outcomes (1)

• IOP at 6 hours after surgery

  IOP will be measured by the same Goldman applanation tonometer used preoperatively

  6 hours postoperatively

Secondary Outcomes (2)

• IOP at 12 hours after surgery

  12 hours postoperatively

• IOP at 24 hours after surgery

  12 hours postoperatively

Study Arms (2)

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

Brinzolamide-Brimonidine fixed combination DRUG

Simbrinza 0.2%-1% Ophthalmic Suspension

Also known as: Simbrinza, 0.2%-1% Ophthalmic Suspension

Brinzolamide-Brimonidine fixed combination

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo cataract surgery by phacoemulsification.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Constantine Georgakopoulos, MD, PhD

  Medical School, University of Patras, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Ophthalmology

Model Details: Prospective randomized double-masked comparative study

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 11, 2018
• Study Start: September 4, 2017
• Primary Completion: March 20, 2018
• Study Completion: April 6, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

GR (1)