GlaucomaPhase 3NCT01830140
A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
A Phase 3 study testing Bimatoprost 0.01% and Bimatoprost 0.03% in people with Glaucoma and Ocular Hypertension, run by Allergan at 2 sites in United States.
Trial summary
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT). 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 0.01% and Bimatoprost 0.03%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of glaucoma or ocular hypertension
Who cannot join
- Active ocular disease other than glaucoma or ocular hypertension
- Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Artesia, California
Study site
El Paso, Texas
About this study
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost 0.01%, Bimatoprost 0.03%
- 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 0.01%Drug
Also called LUMIGAN® 0.01%
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03%Drug
Also called LUMIGAN® 0.03%
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost 0.01% | Experimental | Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. Receives: Drug: Bimatoprost 0.01% |
| Bimatoprost 0.03% | Active comparator | Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. Receives: Drug: Bimatoprost 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.
Measured: Baseline, 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 466 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
- NCT01830140
- Sponsor's protocol ID
- 192024-081
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2013
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01830140
- Acronym / sponsor ID
- 192024-081
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Posted 6 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost 0.01% | Experimental | Drug: Bimatoprost 0.01%Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. |
| Bimatoprost 0.03% | Active comparator | Drug: Bimatoprost 0.03%Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of glaucoma or ocular hypertension
Key exclusion criteria (2 listed)
- Active ocular disease other than glaucoma or ocular hypertension
- Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
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 0.01%Also: LUMIGAN® 0.01%Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks. | Drug | Bimatoprost 0.01% |
| Bimatoprost 0.03%Also: LUMIGAN® 0.03%Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks. | Drug | Bimatoprost 0.03% |
Primary outcome
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
Time frame: Baseline, 6 Weeks
Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost 0.01% and Bimatoprost 0.03% in people with Glaucoma and Ocular Hypertension, run by Allergan at 2 sites 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 1 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 May 2015. 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. 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 6 May 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?
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye (time frame: Baseline, 6 Weeks). 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 May 2015.