Posterior Capsule OpacificationPhase 4NCT03192826
Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy
A Phase 4 study testing Brinzolamide/Brimonidine FC, Brimonidine 0.2% and Artificial tears in people with Posterior Capsule Opacification and Ocular Hypertension, run by University Hospital of Patras at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posterior Capsule Opacification, Ocular Hypertension
- What is being tested?
- Brinzolamide/Brimonidine FC, Brimonidine 0.2% and Artificial tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jun 2016to 8 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Being tested
- Brinzolamide/Brimonidine FC, Brimonidine 0.2%, Artificial tears
- Keywords
- Nd-YAG capsulotomy, ocular hypertension, brimonidine, brinzolamide
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide/Brimonidine FCDrug
Also called SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Brimonidine 0.2%Drug
Also called ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Artificial tearsDrug
Also called TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide/Brimonidine FC | Active comparator | 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Receives: Drug: Brinzolamide/Brimonidine FC |
| Brimonidine 0.2% | Active comparator | 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Receives: Drug: Brimonidine 0.2% |
| Artificial tears | Placebo comparator | 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start20 Jun 2016
- Primary completion8 Jul 2017
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posterior Capsule OpacificationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double masked comparative study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 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
- Constantinos Georgakopoulos, MD, PhD, Study director, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192826
- Sponsor's protocol ID
- 8393 / 26- 4- 2016
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2017
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03192826
- Acronym / sponsor ID
- 8393 / 26- 4- 2016
- Keywords
- Nd-YAG capsulotomy, ocular hypertension, brimonidine, brinzolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 8 Jul 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, double masked comparative study
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide/Brimonidine FC | Active comparator | Drug: Brinzolamide/Brimonidine FC1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy |
| Brimonidine 0.2% | Active comparator | Drug: Brimonidine 0.2%1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy |
| Artificial tears | Placebo comparator | Drug: Artificial tears1 drop of artificial tears 1 hour before Nd-YAG capsulotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
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 FCAlso: SIMBRINZA (brinzolamide/brimonidine 1%/0.2%), Alcon Lab. Ltd1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy | Drug | Brinzolamide/Brimonidine FC |
| Brimonidine 0.2%Also: ALPHAGAN (brimonidine tartrate 0.2%) Allergan Pharm. Ltd1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy | Drug | Brimonidine 0.2% |
| Artificial tearsAlso: TEARS NATURALE EY.DRO.SOL 0.1%+0.3% Alcon Laboratories Ltd1 drop of artificial tears 1 hour before Nd-YAG capsulotomy | Drug | Artificial tears |
Primary outcome
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
Time frame: 1 hour
Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy
Time frame: 3 hours
Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
Time frame: 24 hours
Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
Time frame: 1 week
Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Constantinos Georgakopoulos, MD, PhD study director
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brinzolamide/Brimonidine FC, Brimonidine 0.2% and Artificial tears in people with Posterior Capsule Opacification and Ocular Hypertension, 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 9 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 16 Jul 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy (time frame: 1 hour). The study lists 4 primary outcomes in all. 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 16 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.