GlaucomaPhase 4NCT00759941

A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin

A Phase 4 study testing Brinzolamide 1% ophthalmic solution (Azopt) and Latanoprost 0.005% ophthalmic solution (Xalatan) in people with Glaucoma, run by Alcon Research at 1 site in United States.

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 was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure. Read more about this study

Who is it for?: Ages 35 years and older
Conditions the study is for: Glaucoma
What is being tested?: Brinzolamide 1% ophthalmic solution (Azopt) and Latanoprost 0.005% ophthalmic solution (Xalatan)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Jul 2009
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 35 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.
Other protocol-defined inclusion criteria applied.

Who cannot join

Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.
Argon laser trabeculoplasty or phacoemulsification within the last 3 months.
Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.
Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).
History of uveitis or previous intraocular inflammation (other than post-operatively).
Hypersensitivity to sulfa, or benzalkonium chloride.
History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular).
Other protocol-defined exclusion criteria applied.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin

Conditions: Glaucoma
Being tested: Brinzolamide 1% ophthalmic solution (Azopt), Placebo eye drops, Latanoprost 0.005% ophthalmic solution (Xalatan)
Keywords: Glaucoma
Medical subject headings: Glaucoma

What participants receive

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

Brinzolamide 1% ophthalmic solution (Azopt)Drug
Also called AZOPT
One drop three times a day in both eyes for 3 months
Placebo eye dropsDrug
One drop three times a day in both eyes for 3 months
Latanoprost 0.005% ophthalmic solution (Xalatan)Drug
Also called Xalatan
One drop once a day in both eyes for 3 months

Study groups in NCT00759941
Study group	Role	What they receive
Xalatan + Azopt	Experimental	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. Receives: Drug: Brinzolamide 1% ophthalmic solution (Azopt); Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)
Xalatan + Placebo	Active comparator	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months. Receives: Drug: Placebo eye drops; Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)

What is being measured

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

Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Measured: Day 0, 3 months
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Measured: Day 0, 3 months
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Measured: Day 0, 3 months
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM \& 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.
Measured: Day 0, 3 months

Timeline

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

Oct 2007Jul 2009

First posted25 Sep 2008 (estimated)
Study startOct 2007
Primary completionJul 2009
Study completionJul 2009

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00759941
Sponsor's protocol ID: SMA-07-08
Status last verified: Jul 2012
First submitted: 24 Sep 2008
Last updated: 13 Jan 2014
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin
ClinicalTrials.gov ID: NCT00759941
Acronym / sponsor ID: SMA-07-08
Conditions: Glaucoma
Keywords: Glaucoma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 16 Aug 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Xalatan + Azopt	Experimental	Drug: Brinzolamide 1% ophthalmic solution (Azopt), Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
Xalatan + Placebo	Active comparator	Drug: Placebo eye drops, Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.
Other protocol-defined inclusion criteria applied.

Key exclusion criteria (8 listed)

Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.
Argon laser trabeculoplasty or phacoemulsification within the last 3 months.
Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.
Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).
History of uveitis or previous intraocular inflammation (other than post-operatively).

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% ophthalmic solution (Azopt)Also: AZOPTOne drop three times a day in both eyes for 3 months	Drug	Xalatan + Azopt
Placebo eye dropsOne drop three times a day in both eyes for 3 months	Drug	Xalatan + Placebo
Latanoprost 0.005% ophthalmic solution (Xalatan)Also: XalatanOne drop once a day in both eyes for 3 months	Drug	Xalatan + Azopt, Xalatan + Placebo

Primary outcome

Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
Time frame: Day 0, 3 months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
Time frame: Day 0, 3 months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
Time frame: Day 0, 3 months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
Time frame: Day 0, 3 months
Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM \& 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.

Results and safety

Results posted to the registry on 16 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xalatan + Azopt	42	39
Xalatan + Placebo	44	43

Primary outcome: Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months

Time frame: Day 0, 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	Xalatan + Azopt n = 40	Xalatan + Placebo n = 44
Value	-3.13 (3.03)	-2.57 (2.63)

Population analysed: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Primary outcome: Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months

Time frame: Day 0, 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	Xalatan + Azopt n = 40	Xalatan + Placebo n = 44
Value	-3.30 (2.36)	-2.48 (2.92)

Population analysed: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Primary outcome: Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months

Time frame: Day 0, 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	Xalatan + Azopt n = 40	Xalatan + Placebo n = 44
Value	-3.00 (3.40)	-2.33 (3.18)

Population analysed: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Primary outcome: Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months

Time frame: Day 0, 3 months. Mean (Standard Deviation). Unit: mmHg

Measure	Xalatan + Azopt n = 40	Xalatan + Placebo n = 44
Value	-3.20 (2.55)	-2.48 (2.37)

Population analysed: All enrolled. Two subjects were excluded from the efficacy analysis due to an adverse event (1) and use of medication not permitted (1).

Adverse events

Time frame: Adverse events were collected for the duration of the study: 15-OCT-2007 to 31-JUL-2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xalatan + Azopt	0 of 42 (0%)	0 of 42 (0%)	Not reported
Xalatan + Placebo	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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.

The record lists no contact. Use the official record to reach the sponsor.

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% ophthalmic solution (Azopt) and Latanoprost 0.005% ophthalmic solution (Xalatan) in people with Glaucoma, run by Alcon Research at 1 site in United States.

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 3 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 13 Jan 2014. 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 United States. 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.

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 Aug 2012). 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 Intraocular Pressure, 8 AM, at 3 Months (time frame: Day 0, 3 months). 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?

On the ClinicalTrials.gov record for NCT00759941.

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 13 Jan 2014.