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

University Hospital of Patras

Status and phase: Completed; Phase 4

Conditions: Posterior Capsule Opacification; Ocular Hypertension

Treatments: Drug: Brimonidine 0.2%; Drug: Brinzolamide/Brimonidine FC; Drug: Artificial tears

Study type: Interventional

Funder types: Other

Identifiers

NCT03192826

8393 / 26- 4- 2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 3 patient groups, including a placebo group

Brinzolamide/Brimonidine FC

Active Comparator group

Description:

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Treatment:

Drug: Brinzolamide/Brimonidine FC

Brimonidine 0.2%

Active Comparator group

Description:

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

Treatment:

Drug: Brimonidine 0.2%

Artificial tears

Placebo Comparator group

Description:

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

Treatment:

Drug: Artificial tears