GlaucomaPhase 2NCT02140060

6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase 2 study testing Dose Level A / Brinzolamide 1% ophthalmic suspension, Dose Level B / Brinzolamide 1% ophthalmic suspension and Dose Level C / Brinzolamide 1% ophthalmic suspension in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Dose Level A / Brinzolamide 1% ophthalmic suspension, Dose Level B / Brinzolamide 1% ophthalmic suspension and Dose Level C / Brinzolamide 1% ophthalmic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 327 participants
Where: No sites listed yet
Study dates: Jun 2014to Nov 2014
Phase: Phase 2
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

Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be >36 mmHg at any time point;
Able to understand and sign an informed consent form;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;
Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;
Chronic, recurrent or severe inflammatory eye disease;
Ocular trauma within the past 6 months prior to the Screening Visit;
Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;
Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;

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Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);
Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;
Intraocular surgery within the past 6 months prior to the Screening Visit;
Ocular laser surgery within the past 3 months prior to the Screening Visit;
Any abnormality preventing reliable applanation tonometry;
Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;
Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator;
Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (> 1 g daily) salicylate therapy;
Use of any additional topical or systemic ocular hypotensive medication during the study;
Concurrent use of glucocorticoids administered by any route;
Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);
Therapy with another investigational agent within 30 days prior to the Screening Visit;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: A 6-Week Proof-of-Concept Study Evaluating the Safety and IOP-Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Read the detailed description

This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.

Conditions: Glaucoma, Ocular Hypertension
Being tested: Dose Level A / Brinzolamide 1% ophthalmic suspension, Dose Level B / Brinzolamide 1% ophthalmic suspension, Dose Level C / Brinzolamide 1% ophthalmic suspension, Brinzolamide 1% ophthalmic suspension AZOPT®, Travoprost 0.004% ophthalmic solution TRAVATAN Z®
Keywords: Glaucoma, Ocular, Hypertension, OAG, POAG, OHT
Medical subject headings: Glaucoma, Ocular Hypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dose Level A / Brinzolamide 1% ophthalmic suspensionDrug
Fixed combination
Dose Level B / Brinzolamide 1% ophthalmic suspensionDrug
Fixed combination
Dose Level C / Brinzolamide 1% ophthalmic suspensionDrug
Fixed combination
Brinzolamide 1% ophthalmic suspension AZOPT®Drug
Also called AZOPT®
Travoprost 0.004% ophthalmic solution TRAVATAN Z®Drug
Also called TRAVATAN Z®
Travoprost solution vehicleDrug
Inactive ingredients used for masking purposes
Brinzolamide suspension vehicleDrug
Inactive ingredients used for masking purposes

Study groups in NCT02140060
Study group	Role	What they receive
TravA/Brinz	Experimental	Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Receives: Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension; Drug: Travoprost solution vehicle
TravB/Brinz	Experimental	Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Receives: Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension; Drug: Travoprost solution vehicle
TravC/Brinz	Experimental	Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks Receives: Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension; Drug: Travoprost solution vehicle
AZOPT	Active comparator	Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks Receives: Drug: Brinzolamide 1% ophthalmic suspension AZOPT®; Drug: Travoprost solution vehicle
TRAV Z	Active comparator	Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks Receives: Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®; Drug: Brinzolamide suspension vehicle
TRAV Z + AZOPT	Active comparator	Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks Receives: Drug: Brinzolamide 1% ophthalmic suspension AZOPT®; Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean IOP at Week 6
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.
Measured: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Nov 2014

First posted16 May 2014 (estimated)
Study startJun 2014
Primary completionNov 2014
Study completionNov 2014

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 Alcon ResearchThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02140060
Sponsor's protocol ID: C-14-003
Status last verified: Nov 2015
First submitted: 14 May 2014
Last updated: 29 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-Week Proof-of-Concept Study Evaluating the Safety and IOP-Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT02140060
Acronym / sponsor ID: C-14-003
Conditions: Glaucoma, Ocular Hypertension
Keywords: Glaucoma, Ocular, Hypertension, OAG, POAG, OHT
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 16 May 2014 (estimated)
Results: Posted 29 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
TravA/Brinz	Experimental	Drug: Dose Level A / Brinzolamide 1% ophthalmic suspension, Drug: Travoprost solution vehicleDose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
TravB/Brinz	Experimental	Drug: Dose Level B / Brinzolamide 1% ophthalmic suspension, Drug: Travoprost solution vehicleDose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
TravC/Brinz	Experimental	Drug: Dose Level C / Brinzolamide 1% ophthalmic suspension, Drug: Travoprost solution vehicleDose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
AZOPT	Active comparator	Drug: Brinzolamide 1% ophthalmic suspension AZOPT®, Drug: Travoprost solution vehicleBrinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
TRAV Z	Active comparator	Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®, Drug: Brinzolamide suspension vehicleBrinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
TRAV Z + AZOPT	Active comparator	Drug: Brinzolamide 1% ophthalmic suspension AZOPT®, Drug: Travoprost 0.004% ophthalmic solution TRAVATAN Z®Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be >36 mmHg at any time point;
Able to understand and sign an informed consent form;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (20 listed)

Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;
Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;
Chronic, recurrent or severe inflammatory eye disease;
Ocular trauma within the past 6 months prior to the Screening Visit;
Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;

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
Dose Level A / Brinzolamide 1% ophthalmic suspensionFixed combination	Drug	TravA/Brinz
Dose Level B / Brinzolamide 1% ophthalmic suspensionFixed combination	Drug	TravB/Brinz
Dose Level C / Brinzolamide 1% ophthalmic suspensionFixed combination	Drug	TravC/Brinz
Brinzolamide 1% ophthalmic suspension AZOPT®Also: AZOPT®	Drug	AZOPT, TRAV Z + AZOPT
Travoprost 0.004% ophthalmic solution TRAVATAN Z®Also: TRAVATAN Z®	Drug	TRAV Z, TRAV Z + AZOPT
Travoprost solution vehicleInactive ingredients used for masking purposes	Drug	AZOPT, TravA/Brinz, TravB/Brinz, TravC/Brinz
Brinzolamide suspension vehicleInactive ingredients used for masking purposes	Drug	TRAV Z

Primary outcome

Mean IOP at Week 6
Time frame: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.

Results and safety

Results posted to the registry on 29 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TravA/Brinz	44	44
TravB/Brinz	44	44
TravC/Brinz	44	44
TRAV Z	45	43
AZOPT	45	44
TRAV Z + AZOPT	44	43

Primary outcome: Mean IOP at Week 6

Time frame: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM. Mean (Standard Error). Unit: mmHg

Measure	TravA/Brinz n = 44	TravB/Brinz n = 44	TravC/Brinz n = 44	TRAV Z n = 45	AZOPT n = 45	TRAV Z + AZOPT n = 43
8 AM	20.2 (0.52)	18.7 (0.48)	19.9 (0.58)	19.3 (0.48)	22.0 (0.45)	20.3 (0.72)
10 AM	18.9 (0.47)	17.2 (0.35)	18.2 (0.55)	17.4 (0.47)	19.7 (0.50)	18.2 (0.59)
12 PM	18.9 (0.47)	17.3 (0.50)	17.7 (0.51)	17.2 (0.50)	19.5 (0.53)	18.0 (0.57)
4PM	18.5 (0.46)	17.5 (0.43)	17.3 (0.46)	17.6 (0.44)	19.1 (0.50)	18.0 (0.52)
8 PM, n=44, 44, 44, 43, 45, 43	18.4 (0.43)	17.5 (0.39)	17.2 (0.40)	17.3 (0.43)	19.3 (0.48)	18.1 (0.49)

Population analysed: This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm, respectively.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 11 weeks). AEs were reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TravA/Brinz	0 of 44 (0%)	7 of 44 (15.9%)	Not reported
TravB/Brinz	0 of 44 (0%)	11 of 44 (25%)	Not reported
TravC/Brinz	0 of 44 (0%)	15 of 44 (34.1%)	Not reported
TRAV Z	1 of 45 (2.2%)	10 of 45 (22.2%)	Not reported
AZOPT	0 of 45 (0%)	9 of 45 (20%)	Not reported
TRAV Z + AZOPT	0 of 44 (0%)	13 of 44 (29.5%)	Not reported
Pre-treatment	1 of 327 (0.3%)	1 of 327 (0.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Sr. Clinical Manager, GCRA, Pharma study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

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 20 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 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Dec 2015). 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 IOP at Week 6 (time frame: Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02140060.

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 29 Dec 2015.