Phase 4
N=79
Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy
Posterior Capsule Opacification · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03192826 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy — 15.6; 15.7; 15.2; 13.7 mmHg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brinzolamide/Brimonidine FC (Drug); Brimonidine 0.2% (Drug); Artificial tears (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University Hospital of Patras
- Primary completion
- Jul 2017
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 |
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.
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
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.