Ocular HypertensionPhase 3NCT00332540
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
A Phase 3 study testing bimatoprost/timolol fixed combination in people with Ocular Hypertension, run by Allergan at 2 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination 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
- What is being tested?
- bimatoprost/timolol fixed combination
- How many people
- 520 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2001to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
- Patient requires IOP-lowering drug in both eyes
Who cannot join
- Uncontrolled medical condition
- Contraindication to beta-adrenoceptor antagonist therapy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension
- Conditions
- Ocular Hypertension
- Being tested
- bimatoprost/timolol fixed combination
- Medical subject headings
- Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost/timolol fixed combinationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startAug 2001
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332540
- Sponsor's protocol ID
- 192024-018T
- Status last verified
- May 2011
- First submitted
- 30 May 2006
- Last updated
- 30 May 2011
- Results posted
- No
Publications
Lewis RA, Gross RL, Sall KN, Schiffman RM, Liu CC, Batoosingh AL; Ganfort Investigators Group II. The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2010 Aug;19(6):424-6. doi: 10.1097/IJG.0b013e3181bdb586. No abstract available.
PubMed 19855289
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00332540
- Acronym / sponsor ID
- 192024-018T
- Conditions
- Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 1 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of ocular hypertension or chronic glaucoma in both eyes
- Patient requires IOP-lowering drug in both eyes
Key exclusion criteria (2 listed)
- Uncontrolled medical condition
- Contraindication to beta-adrenoceptor antagonist therapy
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/timolol fixed combination | Drug | – |
Primary outcome
IOP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
- Derived from this study: PubMed 19855289Lewis RA, Gross RL, Sall KN, Schiffman RM, Liu CC, Batoosingh AL; Ganfort Investigators Group II. The safety and efficacy of bimatoprost/timolol fixed combination: a 1-year double-masked, randomized parallel comparison to its individual components in patients with glaucoma or ocular hypertension. J Glaucoma. 2010 Aug;19(6):424-6. doi: 10.1097/IJG.0b013e3181bdb586. No abstract available.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bimatoprost/timolol fixed combination in people with Ocular Hypertension, run by Allergan at 2 sites in 2 countries.
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 30 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IOP. 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 NCT00332540, which also lists 1 linked publication.
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 30 May 2011.