Ocular HypertensionPhase 4NCT00541242

Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

A Phase 4 study testing bimatoprost 0.03% eye drops and latanoprost 0.005% eye drops in people with Ocular Hypertension and Glaucoma, run by Allergan 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 study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ocular Hypertension, Glaucoma
What is being tested?: bimatoprost 0.03% eye drops and latanoprost 0.005% eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 586 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Aug 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ocular hypertension or chronic glaucoma
Patient requires IOP-lowering therapy in both eyes

Who cannot join

Uncontrolled medical conditions
Hypersensitivity to study medications

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Newport Beach, California

Other trials in United States

About this study

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Conditions: Ocular Hypertension, Glaucoma
Being tested: bimatoprost 0.03% eye drops, latanoprost 0.005% eye drops
Medical subject headings: Ocular Hypertension, Glaucoma

What participants receive

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

bimatoprost 0.03% eye dropsDrug
Also called latanoprost = Xalatan®, bimatoprost = Lumigan®
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks
latanoprost 0.005% eye dropsDrug
Also called Xalatan®
Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks

Study groups in NCT00541242
Study group	Role	What they receive
1	Active comparator	bimatoprost 0.03% eye drops Receives: Drug: bimatoprost 0.03% eye drops
2	Active comparator	latanoprost 0.005% eye drops Receives: Drug: latanoprost 0.005% eye drops

What is being measured

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

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Measured: Baseline, Week 12
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Measured: Baseline, Week 18

Timeline

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

Dec 2007Aug 2008

First posted10 Oct 2007 (estimated)
Study startDec 2007
Primary completionAug 2008
Study completionAug 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 Ocular HypertensionStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 586 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00541242
Sponsor's protocol ID: 192024-034
Status last verified: Sep 2011
First submitted: 5 Oct 2007
Last updated: 27 Oct 2011
Results posted: Yes, on ClinicalTrials.gov

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 Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT00541242
Acronym / sponsor ID: 192024-034
Conditions: Ocular Hypertension, Glaucoma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 586 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 10 Oct 2007 (estimated)
Results: Posted 27 Oct 2011

Clinical summary

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

The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Study design

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

Arm	Type	Receives
1	Active comparator	Drug: bimatoprost 0.03% eye dropsbimatoprost 0.03% eye drops
2	Active comparator	Drug: latanoprost 0.005% eye dropslatanoprost 0.005% eye drops

Who may qualify

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

Key inclusion criteria (2 listed)

Ocular hypertension or chronic glaucoma
Patient requires IOP-lowering therapy in both eyes

Key exclusion criteria (2 listed)

Uncontrolled medical conditions
Hypersensitivity to study medications

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
bimatoprost 0.03% eye dropsAlso: latanoprost = Xalatan®, bimatoprost = Lumigan®Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks	Drug	1
latanoprost 0.005% eye dropsAlso: Xalatan®Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks	Drug	2

Primary outcome

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12
Time frame: Baseline, Week 12
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18
Time frame: Baseline, Week 18
Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP.

Results and safety

Results posted to the registry on 27 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimatoprost 0.03% Eye Drops	0	0
Latanoprost 0.005% Eye Drops	586	586

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Bimatoprost 0.03% Eye Drops n = 270	Latanoprost 0.005% Eye Drops n = 272
Baseline	21.90 (3.656)	22.16 (3.569)
Week 12	-5.64 (2.968)	-4.89 (2.872)

Population analysed: Modified Intent-to-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and had at least a baseline and one follow-up visit measurement of IOP after receiving the study medication.

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18

Time frame: Baseline, Week 18. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Bimatoprost 0.03% Eye Drops n = 270	Latanoprost 0.005% Eye Drops n = 272
Baseline	21.90 (3.656)	22.16 (3.569)
Week 18	-5.77 (3.023)	-5.09 (2.709)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimatoprost 0.03% Eye Drops	4 of 269 (1.5%)	59 of 269 (21.9%)	Not reported
Latanoprost 0.005% Eye Drops	11 of 586 (1.9%)	89 of 586 (15.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ocular Hypertension

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
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Recruiting
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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.

Medical Director study director

Allergan

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 bimatoprost 0.03% eye drops and latanoprost 0.005% eye drops in people with Ocular Hypertension and Glaucoma, run by Allergan 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 2 inclusion and 2 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 27 Oct 2011. 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 27 Oct 2011). 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?

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 (time frame: Baseline, Week 12). The study lists 2 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 NCT00541242.

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 27 Oct 2011.