CataractNCT03494257
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
A study testing Brinzolamide-Brimonidine fixed combination in people with Cataract and Intraocular Pressure, run by University Hospital of Patras at 1 site in Greece.
Trial summary
This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery. Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract, Intraocular Pressure
- What is being tested?
- Brinzolamide-Brimonidine fixed combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGreece
- Study dates
- 4 Sep 2017to 6 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo cataract surgery by phacoemulsification.
Who cannot join
- previous ocular surgery
- ocular hypertension
- pseudoexfoliation syndrome
- pigment dispersion syndrome
- glaucoma
- history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
- hypersensitivity to sulfonamides or brimonidine
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery.
Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.
The treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination immediately after surgery, and the control group will receive no treatment. The IOP will be measured preoperatively and at 6, 12, and 24 hours postoperatively.
Read the detailed description
Phacoemulsification with the use of an ophthalmic viscosurgical device (OVD) and implantation of a foldable intraocular lens (IOL) is the preferred technique for cataract surgery today.
OVDs in spite of their advantages in phacoemulsification surgery, have been correlated with intraocular pressure (IOP) increase within the first 24 hours postoperatively. This constitutes a frequent short-term complication of cataract surgery and can lead to corneal edema and pain. This IOP rise may also increase the risk of retinal artery occlusion, ischemic optic neuropathy, and deterioration of preexisting glaucomatous nerve damage.
DuoVisc, an OVD that consists of Viscoat (chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) in combination with Provisc (sodium hyaluronate 1.0%) is the most frequently used OVD during cataract surgery.
To prevent IOP spikes postoperatively, various antiglaucoma agents have been used. Brinzolamide is a carbonic anhydrase inhibitor that acts upon the ciliary processes and reduces aqueous humor secretion.Brimonidine is a highly selective a2-adrenergic agonist that increases uveoscleral outflow and reduces aqueous humor production.
- Conditions
- Cataract, Intraocular Pressure
- Being tested
- Brinzolamide-Brimonidine fixed combination
- Keywords
- phacoemulsification, intraocular pressure, cataract, brinzolamide, brimonidinde, fixed combination
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide-Brimonidine fixed combinationDrug
Also called Simbrinza, 0.2%-1% Ophthalmic Suspension
Simbrinza 0.2%-1% Ophthalmic Suspension
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide-Brimonidine fixed combination | Active comparator | 1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery Receives: Drug: Brinzolamide-Brimonidine fixed combination |
| No topical IOP reducing medication | No intervention | No IOP reducing drops instilled after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP at 6 hours after surgery
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Measured: 6 hours postoperatively
Secondary outcomes (2)
IOP at 12 hours after surgery
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Measured: 12 hours postoperatively
IOP at 24 hours after surgery
IOP will be measured by the same Goldman applanation tonometer used preoperatively
Measured: 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start4 Sep 2017
- Primary completion20 Mar 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized double-masked comparative study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras
- Investigators
- Constantine Georgakopoulos, MD, PhD, Principal investigator, Medical School, University of Patras, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494257
- Sponsor's protocol ID
- 58/15.02.2018/5104
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
- ClinicalTrials.gov ID
- NCT03494257
- Acronym / sponsor ID
- 58/15.02.2018/5104
- Conditions
- Cataract, Intraocular Pressure
- Keywords
- phacoemulsification, intraocular pressure, cataract, brinzolamide, brimonidinde, fixed combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery.
Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.
The treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination immediately after surgery, and the control group will receive no treatment. The IOP will be measured preoperatively and at 6, 12, and 24 hours postoperatively.
Detailed description
Phacoemulsification with the use of an ophthalmic viscosurgical device (OVD) and implantation of a foldable intraocular lens (IOL) is the preferred technique for cataract surgery today.
OVDs in spite of their advantages in phacoemulsification surgery, have been correlated with intraocular pressure (IOP) increase within the first 24 hours postoperatively. This constitutes a frequent short-term complication of cataract surgery and can lead to corneal edema and pain. This IOP rise may also increase the risk of retinal artery occlusion, ischemic optic neuropathy, and deterioration of preexisting glaucomatous nerve damage.
DuoVisc, an OVD that consists of Viscoat (chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) in combination with Provisc (sodium hyaluronate 1.0%) is the most frequently used OVD during cataract surgery.
To prevent IOP spikes postoperatively, various antiglaucoma agents have been used. Brinzolamide is a carbonic anhydrase inhibitor that acts upon the ciliary processes and reduces aqueous humor secretion.Brimonidine is a highly selective a2-adrenergic agonist that increases uveoscleral outflow and reduces aqueous humor production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective randomized double-masked comparative study
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide-Brimonidine fixed combination | Active comparator | Drug: Brinzolamide-Brimonidine fixed combination1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery |
| No topical IOP reducing medication | No intervention | –No IOP reducing drops instilled after surgery |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo cataract surgery by phacoemulsification.
Key exclusion criteria (7 listed)
- previous ocular surgery
- ocular hypertension
- pseudoexfoliation syndrome
- pigment dispersion syndrome
- glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brinzolamide-Brimonidine fixed combinationAlso: Simbrinza, 0.2%-1% Ophthalmic SuspensionSimbrinza 0.2%-1% Ophthalmic Suspension | Drug | Brinzolamide-Brimonidine fixed combination |
Primary outcome
IOP at 6 hours after surgery
Time frame: 6 hours postoperatively
IOP will be measured by the same Goldman applanation tonometer used preoperatively
2 secondary outcomes
IOP at 12 hours after surgery
Time frame: 12 hours postoperatively
IOP at 24 hours after surgery
Time frame: 12 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine Georgakopoulos, MD, PhD principal investigator
Medical School, University of Patras, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brinzolamide-Brimonidine fixed combination in people with Cataract and Intraocular Pressure, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP at 6 hours after surgery (time frame: 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.