GlaucomaPhase 3NCT01426113
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
A Phase 3 study testing bimatoprost ophthalmic solution formulation A and timolol ophthalmic solution in people with Glaucoma, run by Allergan at 9 sites in 7 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma. Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- bimatoprost ophthalmic solution formulation A and timolol ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 9 sitesin 7 countries
- Study dates
- Sep 2011to Oct 2014
- 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 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of congenital, juvenile glaucoma
- Requires treatment with IOP-lowering medication in one or both eyes
Who cannot join
- Surgical intervention is indicated or planned to lower IOP
- Abnormally low body weight (below 5th percentile)
- Any active eye infection or disease
- Anticipated use of contact lenses during the study
- Topical ocular steroid use within 2 months
- History of ocular trauma in either eye
- Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
About this study
The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
- Conditions
- Glaucoma
- Being tested
- bimatoprost ophthalmic solution formulation A, timolol ophthalmic solution, bimatoprost vehicle
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost ophthalmic solution formulation ADrug
1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks.
timolol ophthalmic solutionDrug
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
bimatoprost vehicleDrug
1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost ophthalmic solution formulation A and vehicle | Experimental | 1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. Receives: Drug: bimatoprost ophthalmic solution formulation A; Drug: bimatoprost vehicle |
| timolol ophthalmic solution | Active comparator | 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. Receives: Drug: timolol ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Study terminated due to corporate decision.
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 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
- NCT01426113
- Sponsor's protocol ID
- 192024-056
- Status last verified
- Sep 2015
- First submitted
- 29 Aug 2011
- Last updated
- 2 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT01426113
- Acronym / sponsor ID
- 192024-056
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to corporate decision.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 2 Oct 2015
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 a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bimatoprost ophthalmic solution formulation A and vehicle | Experimental | Drug: bimatoprost ophthalmic solution formulation A, Drug: bimatoprost vehicle1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks. |
| timolol ophthalmic solution | Active comparator | Drug: timolol ophthalmic solution1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of congenital, juvenile glaucoma
- Requires treatment with IOP-lowering medication in one or both eyes
Key exclusion criteria (7 listed)
- Surgical intervention is indicated or planned to lower IOP
- Abnormally low body weight (below 5th percentile)
- Any active eye infection or disease
- Anticipated use of contact lenses during the study
- Topical ocular steroid use within 2 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 ophthalmic solution formulation A1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks. | Drug | bimatoprost ophthalmic solution formulation A and vehicle |
| timolol ophthalmic solution1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks. | Drug | timolol ophthalmic solution |
| bimatoprost vehicle1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks. | Drug | bimatoprost ophthalmic solution formulation A and vehicle |
Primary outcome
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Time frame: Baseline, Week 6
IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
- 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
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bimatoprost ophthalmic solution formulation A and timolol ophthalmic solution in people with Glaucoma, run by Allergan at 9 sites in 7 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 7 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: stopped early, as of the sponsor's last update on 2 Oct 2015. 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 Italy, Philippines, United States, France, South Korea and 2 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 2 Oct 2015). 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 Intraocular Pressure (IOP) in the Study Eye (time frame: Baseline, Week 6). 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 2 Oct 2015.