GlaucomaPhase 4NCT00471380

A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension

A Phase 4 study testing travoprost 0.004% and brinzolamide 1% in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Italy.

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

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: travoprost 0.004% and brinzolamide 1%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteItaly
Study dates: Mar 2007to Oct 2008
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension
Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM
Stable visual field in last 6 months
6 weeks wash out from previous topical medications

Who cannot join

Trial locations and contacts

1 site in 1 country.

Italy1 site

Catania
Catania, 95123

Other trials in Italy

About this study

Conditions: Glaucoma, Ocular Hypertension
Being tested: travoprost 0.004% and brinzolamide 1%, fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

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

travoprost 0.004% and brinzolamide 1%Drug
Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)
fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicleDrug
group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).

Study groups in NCT00471380
Study group	Role	What they receive
Crossover group ABB	Active comparator	3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks) Receives: Drug: travoprost 0.004% and brinzolamide 1%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle
Crossover group BAA	Active comparator	3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks). Receives: Drug: travoprost 0.004% and brinzolamide 1%; Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

What is being measured

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

Intra Ocular Pressure (IOP)
Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points
Measured: Baseline, end of each period (week 8, week 16, week 24)

Timeline

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

Mar 2007Oct 2008

First posted9 May 2007 (estimated)
Study startMar 2007
Primary completionOct 2008

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: Crossover
Masking: Double blind
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00471380
Sponsor's protocol ID: IT-04-04
Other IDs: EudraCT 200600362737
Status last verified: Mar 2010
First submitted: 8 May 2007
Last updated: 16 Mar 2010
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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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV Study of Travoprost + Brinzolamide to Treat Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT00471380
Acronym / sponsor ID: IT-04-04
Conditions: Glaucoma, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Oct 2008 (actual)
First posted: 9 May 2007 (estimated)
Results: Posted 11 Mar 2010

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: Crossover
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Crossover group ABB	Active comparator	Drug: travoprost 0.004% and brinzolamide 1%, Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
Crossover group BAA	Active comparator	Drug: travoprost 0.004% and brinzolamide 1%, Drug: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Written informed consent
Diagnosis of bilateral Primary open angle glaucoma or ocular hypertension
Intra Ocular Pressure above 19 millimeters mercury at screening visit at 8:00 AM
Stable visual field in last 6 months
6 weeks wash out from previous topical medications

Key exclusion criteria (1 listed)

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
travoprost 0.004% and brinzolamide 1%Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.)	Drug	Crossover group ABB, Crossover group BAA
fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehiclegroup B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).	Drug	Crossover group ABB, Crossover group BAA

Primary outcome

Intra Ocular Pressure (IOP)
Time frame: Baseline, end of each period (week 8, week 16, week 24)
Intra Ocular Pressure, calculated as AUC (area under the curve) of IOP measured from 8.00 a.m. to 8.00 p.m, at different time-points

Results and safety

Results posted to the registry on 11 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crossover Group ABB	22	18
Crossover Group BAA	24	20

Primary outcome: Intra Ocular Pressure (IOP)

Time frame: Baseline, end of each period (week 8, week 16, week 24). Mean (Standard Deviation). Unit: mm Hg (millimeters mercury)*week

Measure	Crossover Group ABB n = 22	Crossover Group BAA n = 24
Week 8	179.20 (25.42)	191.89 (52.59)
Week 16	188.82 (32.05)	196.26 (59.07)
Week 24	201.50 (41.01)	191.93 (41.39)

Adverse events

Time frame: 6 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 22 (0%)	11 of 22 (50%)	Not reported
Treatment B	2 of 24 (8.3%)	3 of 24 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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.

Marcello Fornoni study director

Alcon Research

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 travoprost 0.004% and brinzolamide 1% in people with Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Italy.

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 5 inclusion and 1 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 Mar 2010. 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 Italy. 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 11 Mar 2010). 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?

Intra Ocular Pressure (IOP) (time frame: Baseline, end of each period (week 8, week 16, week 24)). 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 NCT00471380.

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 Mar 2010.