Phase 4 Completed N=79 Randomized Double-blind Prevention

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

Posterior Capsule Opacification · Hypertension

Source: ClinicalTrials.gov NCT03192826 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcomePrimary: Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy — 15.6; 15.7; 15.2; 13.7 mmHg — p=<0.05

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy	15.6; 15.7; 15.2; 13.7; 14.7; 19.5	<0.05 sig
PRIMARY Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy	15.6; 15.7; 15.2; 12.7; 14.7; 19.5	<0.05 sig
PRIMARY Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy	15.6; 15.7; 15.2; 14.6; 15.5; 15.8	<0.05 sig
PRIMARY Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy	15.6; 15.7; 15.2; 15.5; 15.3; 15.6	<0.05 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03192826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.