Glaucoma, Open-AnglePhase 4NCT01243567
Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
A Phase 4 study testing bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution and latanoprost 0.005% ophthalmic solution in people with Glaucoma, Open-Angle, run by Allergan at 2 sites in 2 countries.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution and latanoprost 0.005% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2010to 14 Feb 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary open-angle glaucoma that has never been treated
- Visual Acuity 20/60 or better in each eye
Who cannot join
- Eye surgery within 3 months
- Any refractive eye surgery
- Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
- Eye inflammation or eye infection within 3 months
- Eye trauma within 6 months
- Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution, latanoprost 0.005% ophthalmic solution
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost 0.03%/timolol 0.5% combination ophthalmic solutionDrug
Also called GANFort®
Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
latanoprost 0.005% ophthalmic solutionDrug
Also called Xalatan®
Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution | Active comparator | Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. Receives: Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution |
| latanoprost 0.005% ophthalmic solution | Active comparator | Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months. Receives: Drug: latanoprost 0.005% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
Measured: Baseline, Month 3
Secondary outcomes (4)
Change From Baseline IOP
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
Measured: Baseline, Month 3
Percentage of Patients Reaching a Predefined Target Pressure Threshold
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
Measured: Baseline, Month 3
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Measured: Baseline, Month 3
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study start1 Jun 2010
- Primary completion14 Feb 2012
- Study completion14 Feb 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 Glaucoma, Open-AngleStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 81 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
- NCT01243567
- Sponsor's protocol ID
- MAF-AGN-OPH-GLA-010
- Other IDs
- 2009-012799-28, 2009
- Status last verified
- Apr 2019
- First submitted
- 17 Nov 2010
- Last updated
- 18 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gutierrez-Diaz E, Silva Cotta J, Munoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naive glaucoma patients at high risk of progression: a pilot study. Clin Ophthalmol. 2014 Apr 10;8:725-32. doi: 10.2147/OPTH.S56735. eCollection 2014.
PubMed 24748767
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
- ClinicalTrials.gov ID
- NCT01243567
- Acronym / sponsor ID
- MAF-AGN-OPH-GLA-010
- Conditions
- Glaucoma, Open-Angle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2010 (actual)
- Primary completion
- 14 Feb 2012 (actual)
- Study completion
- 14 Feb 2012 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Posted 26 Feb 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 fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution | Active comparator | Drug: bimatoprost 0.03%/timolol 0.5% combination ophthalmic solutionBimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. |
| latanoprost 0.005% ophthalmic solution | Active comparator | Drug: latanoprost 0.005% ophthalmic solutionLatanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of primary open-angle glaucoma that has never been treated
- Visual Acuity 20/60 or better in each eye
Key exclusion criteria (6 listed)
- Eye surgery within 3 months
- Any refractive eye surgery
- Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
- Eye inflammation or eye infection within 3 months
- Eye trauma within 6 months
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%/timolol 0.5% combination ophthalmic solutionAlso: GANFort®Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. | Drug | bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution |
| latanoprost 0.005% ophthalmic solutionAlso: Xalatan®Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months. | Drug | latanoprost 0.005% ophthalmic solution |
Primary outcome
Change From Baseline in Average Intraocular Pressure (IOP)
Time frame: Baseline, Month 3
IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).
4 secondary outcomes
Change From Baseline IOP
Time frame: Baseline, Month 3
Percentage of Patients Reaching a Predefined Target Pressure Threshold
Time frame: Baseline, Month 3
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Time frame: Baseline, Month 3
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24748767Gutierrez-Diaz E, Silva Cotta J, Munoz-Negrete FJ, Gutierrez-Ortiz C, Morgan-Warren RJ, Maltman J. Bimatoprost/timolol fixed combination versus latanoprost in treatment-naive glaucoma patients at high risk of progression: a pilot study. Clin Ophthalmol. 2014 Apr 10;8:725-32. doi: 10.2147/OPTH.S56735. eCollection 2014.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution and latanoprost 0.005% ophthalmic solution in people with Glaucoma, Open-Angle, 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 6 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 18 Apr 2019. 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 Portugal, Spain. 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 26 Feb 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 Average Intraocular Pressure (IOP) (time frame: Baseline, Month 3). 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 NCT01243567, 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 18 Apr 2019.