GlaucomaPhase 3NCT01177098
Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
A Phase 3 study testing bimatoprost /timolol formulation A fixed combination ophthalmic solution and bimatoprost/timolol fixed combination ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 9 sites in 9 countries.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks 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
- Glaucoma, Ocular Hypertension
- What is being tested?
- bimatoprost /timolol formulation A fixed combination ophthalmic solution and bimatoprost/timolol fixed combination ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Oct 2010to Feb 2012
- Phase
- Phase 3
- 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
- Patient has ocular hypertension or glaucoma in both eyes
- Requires IOP-lowering therapy in each eye
Who cannot join
- Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- History of any eye surgery or laser in either eye within 6 months
- Required chronic use of other eye medications during the study
- Anticipated wearing of contact lenses during the study.
- Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
About this study
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- bimatoprost /timolol formulation A fixed combination ophthalmic solution, bimatoprost/timolol fixed combination ophthalmic solution
- 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.
bimatoprost /timolol formulation A fixed combination ophthalmic solutionDrug
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
bimatoprost/timolol fixed combination ophthalmic solutionDrug
Also called GANFORT®
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost/timolol formulation A | Experimental | One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. Receives: Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution |
| bimatoprost/timolol fixed combination ophthalmic solution | Active comparator | One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks. Receives: Drug: bimatoprost/timolol fixed combination ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Week 12
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Measured: Week 2
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Measured: Week 6
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
Measured: Week 12
Secondary outcomes (2)
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Week 12
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 561 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
- NCT01177098
- Sponsor's protocol ID
- 192024-050
- Other IDs
- 2010-021507-24
- Status last verified
- Mar 2013
- First submitted
- 4 Aug 2010
- Last updated
- 29 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.
PubMed 24667994
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01177098
- Acronym / sponsor ID
- 192024-050
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 12 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bimatoprost/timolol formulation A | Experimental | Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solutionOne drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. |
| bimatoprost/timolol fixed combination ophthalmic solution | Active comparator | Drug: bimatoprost/timolol fixed combination ophthalmic solutionOne drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has ocular hypertension or glaucoma in both eyes
- Requires IOP-lowering therapy in each eye
Key exclusion criteria (5 listed)
- Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- History of any eye surgery or laser in either eye within 6 months
- Required chronic use of other eye medications during the study
- Anticipated wearing of contact lenses during the study.
- Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
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 formulation A fixed combination ophthalmic solutionOne drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks. | Drug | bimatoprost/timolol formulation A |
| bimatoprost/timolol fixed combination ophthalmic solutionAlso: GANFORT®One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks. | Drug | bimatoprost/timolol fixed combination ophthalmic solution |
Primary outcome
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Time frame: Baseline, Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
Time frame: Week 2
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
Time frame: Week 6
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
Time frame: Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
2 secondary outcomes
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24667994Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.
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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
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bimatoprost /timolol formulation A fixed combination ophthalmic solution and bimatoprost/timolol fixed combination ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 9 sites in 9 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 5 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia, Czechia, Germany, Hungary and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2013). 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 Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 (time frame: Baseline, Week 12). 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 NCT01177098, 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 29 Mar 2013.