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NCT03192826 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
Study of the Efficacy of Brinzolamide 1% Plus Brimonidine 0.2% Versus Brimonidine 0.2% in the Prevention of Intraocular Pressure Rise After Nd-YAG Laser Capsulotomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03192826
Other study ID # 8393 / 26- 4- 2016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 20, 2016
Est. completion date July 8, 2017

Study information
Verified date June 2019
Source University Hospital of Patras
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date July 8, 2017
Est. primary completion date July 8, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Brinzolamide/Brimonidine FC
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
• Brimonidine 0.2%
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
• Artificial tears
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Locations
Country Name City State
Greece University Hospital of Patras Patra Achaia

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP 1 hour
Primary Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP 3 hours
Primary Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP 24 hours
Primary Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP 1 week
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