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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brinzolamide/Brimonidine FC | Active Comparator | 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy |
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| Brimonidine 0.2% | Active Comparator | 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy |
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| Artificial tears | Placebo Comparator | 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide/Brimonidine FC | Drug | 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constantinos Georgakopoulos, MD, PhD | University Hospital of Patras | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Patras | Pátrai | Achaia | 26504 | Greece |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brinzolamide/Brimonidine FC | 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy |
| FG001 | Brimonidine 0.2% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2016 |
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This is a prospective, randomized, double masked comparative study
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Patients are masked to their assignment by covering the labels on the bottles of the drugs administered The investigator responsible for the measurement of the intraocular pressure is also masked to the intervention administered to each patient.
| Brimonidine 0.2% | Drug | 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy |
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| Artificial tears | Drug | 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy |
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1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
| FG002 | Artificial Tears | 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Brinzolamide/Brimonidine FC | 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy |
| BG001 | Brimonidine 0.2% | 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy |
| BG002 | Artificial Tears | 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP | Posted | Mean | Standard Deviation | mmHg | 1 hour |
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| 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 | Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP | Posted | Mean | Standard Deviation | mmHg | 3 hours |
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| 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 | Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP | Posted | Mean | Standard Deviation | mmHg | 24 hours |
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| 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 | Comparison of intraocular pressure at 1 weekafter Nd-YAG posterior capsulotomy compared to Baseline IOP | Posted | Mean | Standard Deviation | mmHg | 1 week |
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1month
The same with clinicaltrials.gov Definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brinzolamide/Brimonidine FC | 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy | 0 | 27 | 0 | 27 | 0 | 27 |
| EG001 | Brimonidine 0.2% | 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Artificial Tears | 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy | 0 | 25 | 0 | 25 | 0 | 25 |
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Corneal thickness was not assessed. The measurement of IOP at more time points could have provided more information regarding the effect of BBFC. We could enroll a larger group of patients in order to provide more strength in our analysis
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OPHTHALMOLOGY PATRAS | Patras Medical School | 6975801961 | cgeorg@upatras.gr |
| Jun 23, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D000068438 | Brimonidine Tartrate |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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