GlaucomaPhase 4NCT03150160
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
A Phase 4 study testing brinzolamide 1%/brimonidine 0.2% fixed combination and travoprost 0.004% ophthalmic solution in people with Glaucoma, run by Novartis Pharmaceuticals at 1 site in South Korea.
Trial summary
The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- brinzolamide 1%/brimonidine 0.2% fixed combination and travoprost 0.004% ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2017to 4 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign written informed consent
- Diagnosed with normal tension glaucoma
- Intraocular pressure measurements in at least 1 eye as specified in the protocol
- Willing and able to attend all study visits
Who cannot join
- History of hypersensitivity to any of the study drugs
- Use of medications prohibited by the protocol
- Pregnant or nursing
- Of child-bearing potential unless using contraception, as specified in the protocol
- Any form of glaucoma other than open angle glaucoma in either eye
- Chronic, recurrent or severe inflammatory eye disease
- Ocular trauma or surgery within the past 6 months in either eye; ocular infection or laser surgery within the past 3 months in either eye (all from screening)
- Conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma
The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.
Read the detailed description
This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.
- Conditions
- Glaucoma
- Being tested
- brinzolamide 1%/brimonidine 0.2% fixed combination, Placebo, travoprost 0.004% ophthalmic solution
- Keywords
- travoprost, brinzolamide 1%/brimonidine 0.2%, normal tension glaucoma, intraocular pressure, efficacy, safety
- Medical subject headings
- Glaucoma, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brinzolamide 1%/brimonidine 0.2% fixed combinationDrug
Also called Simbrinza
One drop applied topically to the affected eye(s) in the morning and evening
PlaceboDrug
One drop applied topically to the affected eye(s) in the morning and evening
travoprost 0.004% ophthalmic solutionDrug
Also called Travatan
One drop applied topically to the affected eye(s) in the evening
| Study group | Role | What they receive |
|---|---|---|
| Simbrinza + Travatan | Experimental | Brinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution Receives: Drug: brinzolamide 1%/brimonidine 0.2% fixed combination; Drug: travoprost 0.004% ophthalmic solution |
| Placebo + Travatan | Placebo comparator | Placebo + travoprost 0.004% ophthalmic solution Receives: Drug: Placebo; Drug: travoprost 0.004% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Diurnal IOP at Week 6
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Secondary outcomes (4)
Percent Change From Baseline in IOP at Week 6
IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Mean Diurnal IOP at Week 6
IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis.
Measured: Week 6
Mean Change From Baseline in IOP for Each Time Point at Week 6
IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)
Percentage Change From Baseline in IOP for Each Time Point at Week 6
IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start21 Sep 2017
- Primary completion4 Dec 2017
- Study completion4 Dec 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 GlaucomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150160
- Sponsor's protocol ID
- CQVJ499A2404
- Status last verified
- Oct 2018
- First submitted
- 9 May 2017
- Last updated
- 25 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-week, Double Masked, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Twice-daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to Travoprost 0.004% in Reducing Intraocular Pressure in Patients With Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT03150160
- Acronym / sponsor ID
- CQVJ499A2404
- Conditions
- Glaucoma
- Keywords
- travoprost, brinzolamide 1%/brimonidine 0.2%, normal tension glaucoma, intraocular pressure, efficacy, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 25 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the incremental intraocular pressure (IOP) lowering that is achieved when Simbrinza is used adjunctively to Travatan in patients with normal tension glaucoma that may benefit from further IOP lowering.
Detailed description
This study was prematurely terminated due to administrative reasons and not due to any safety or efficacy concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a multicenter, randomized, double-masked, two-arm, placebo-controlled, parallel group study in patients with normal tension glaucoma who were insufficiently controlled on travoprost 0.004% (Travatan) monotherapy.
| Arm | Type | Receives |
|---|---|---|
| Simbrinza + Travatan | Experimental | Drug: brinzolamide 1%/brimonidine 0.2% fixed combination, Drug: travoprost 0.004% ophthalmic solutionBrinzolamide 1%/brimonidine 0.2% fixed combination + travoprost 0.004% ophthalmic solution |
| Placebo + Travatan | Placebo comparator | Drug: Placebo, Drug: travoprost 0.004% ophthalmic solutionPlacebo + travoprost 0.004% ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign written informed consent
- Diagnosed with normal tension glaucoma
- Intraocular pressure measurements in at least 1 eye as specified in the protocol
- Willing and able to attend all study visits
Key exclusion criteria (8 listed)
- History of hypersensitivity to any of the study drugs
- Use of medications prohibited by the protocol
- Pregnant or nursing
- Of child-bearing potential unless using contraception, as specified in the protocol
- Any form of glaucoma other than open angle glaucoma in either eye
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 1%/brimonidine 0.2% fixed combinationAlso: SimbrinzaOne drop applied topically to the affected eye(s) in the morning and evening | Drug | Simbrinza + Travatan |
| PlaceboOne drop applied topically to the affected eye(s) in the morning and evening | Drug | Placebo + Travatan |
| travoprost 0.004% ophthalmic solutionAlso: TravatanOne drop applied topically to the affected eye(s) in the evening | Drug | Placebo + Travatan, Simbrinza + Travatan |
Primary outcome
Mean Change From Baseline in Diurnal IOP at Week 6
Time frame: Baseline, Week 6
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
4 secondary outcomes
Percent Change From Baseline in IOP at Week 6
Time frame: Baseline, Week 6
Mean Diurnal IOP at Week 6
Time frame: Week 6
Mean Change From Baseline in IOP for Each Time Point at Week 6
Time frame: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)
Percentage Change From Baseline in IOP for Each Time Point at Week 6
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 1%/brimonidine 0.2% fixed combination and travoprost 0.004% ophthalmic solution in people with Glaucoma, run by Novartis Pharmaceuticals at 1 site in South Korea.
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 4 inclusion and 8 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 25 Feb 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 South Korea. 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 25 Feb 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?
Mean Change From Baseline in Diurnal IOP at Week 6 (time frame: Baseline, Week 6). 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 25 Feb 2019.