Open-Angle GlaucomaNCT00716742
Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)
An observational study of Open-Angle Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
Trial summary
To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%
- How many people
- 1,099 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2009
- Phase
- Observational
- 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
Study population: Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.
Who may be able to join
- A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
- Patient is having both eyes treated
Who cannot join
- Contraindications per product labelling will apply.
- Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%Drug
Also called Lumigan®, Xalatan®, Travatan®
1 drop in eye(s) every evening
| Study group | Role | What they receive |
|---|---|---|
| 1 | bimatoprost 0.03% latanoprost 0.005% travoprost 0.004% Receives: Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).
Measured: Baseline, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2007
- Study completionSep 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 Open-Angle GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716742
- Sponsor's protocol ID
- Pro2
- Status last verified
- Nov 2011
- First submitted
- 14 Jul 2008
- Last updated
- 6 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT00716742
- Acronym / sponsor ID
- Pro2
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 6 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effectiveness of the newer IOP-lowering therapies, as prescribed in normal clinical practice, in larger patient numbers. Patients will be assessed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: bimatoprost 0.03%, latanoprost 0.005%, and travoprost 0.004%bimatoprost 0.03% latanoprost 0.005% travoprost 0.004% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients can be either: (a) newly diagnosed and require, in the judgment of the treating physician, one of study agents as first-line treatment, (b) have an insufficiently controlled IOP on their current medication (any but not more than two in combination), and a treatment switch to one of study agents is an acceptable option.
Key inclusion criteria (2 listed)
- A diagnosis of Primary Open-Angle Glaucoma or Ocular Hypertension newly diagnosed OR presenting with insufficiently controlled IOP on current medication (in the opinion of the treating physician)
- Patient is having both eyes treated
Key exclusion criteria (2 listed)
- Contraindications per product labelling will apply.
- Patients with any ophthalmic co-morbidity with an influence on visual field deterioration or optic nerve head damage.
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%, latanoprost 0.005%, and travoprost 0.004%Also: Lumigan®, Xalatan®, Travatan®1 drop in eye(s) every evening | Drug | 1 |
Primary outcome
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year
Time frame: Baseline, 1 Year
Change from baseline in bilateral (both eyes) IOP at the 1 year follow-up visit. IOP is a measure of the fluid pressure inside the eye. The bilateral IOP was calculated as an average between both eye's IOP. A negative number change from baseline indicates reduction in IOP (improvement).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- 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.
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?
An observational study of Open-Angle Glaucoma and Ocular Hypertension, 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 6 Jan 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 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?
Change From Baseline in Bilateral Intraocular Pressure (IOP) at One Year (time frame: Baseline, 1 Year). 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 6 Jan 2012.