GlaucomaPhase 2NCT00652496
Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension
A Phase 2 study testing Bimatoprost 0.01% ophthalmic solution, Bimatoprost 0.015% formulation 1 ophthalmic solution and Bimatoprost 0.015% formulation 2 ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site in United States.
Trial summary
This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient 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% ophthalmic solution, Bimatoprost 0.015% formulation 1 ophthalmic solution and Bimatoprost 0.015% formulation 2 ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to May 2005
- Phase
- Phase 2
- 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
- Ocular hypertension or glaucoma in both eyes
- Require IOP-lowering therapy in each eye
Who cannot join
- Uncontrolled systemic disease
- Known allergy or hypersensitivity to bimatoprost
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Bimatoprost 0.01% ophthalmic solution, Bimatoprost 0.015% formulation 1 ophthalmic solution, Bimatoprost 0.015% formulation 2 ophthalmic solution, Bimatoprost 0.02% ophthalmic solution, Bimatoprost 0.03% 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 0.01% ophthalmic solutionDrug
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Bimatoprost 0.015% formulation 1 ophthalmic solutionDrug
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Bimatoprost 0.015% formulation 2 ophthalmic solutionDrug
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Bimatoprost 0.02% ophthalmic solutionDrug
One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop
Bimatoprost 0.03% ophthalmic solutionDrug
Also called LUMIGAN®
Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bimatoprost 0.01% ophthalmic solution Receives: Drug: Bimatoprost 0.01% ophthalmic solution |
| 2 | Experimental | Bimatoprost 0.015% formulation 1 ophthalmic solution Receives: Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution |
| 3 | Experimental | Bimatoprost 0.015% formulation 2 ophthalmic solution Receives: Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution |
| 4 | Experimental | Bimatoprost 0.02% ophthalmic solution Receives: Drug: Bimatoprost 0.02% ophthalmic solution |
| 5 | Active comparator | Bimatoprost 0.03% ophthalmic solution Receives: Drug: Bimatoprost 0.03% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Measured: Day 5
Secondary outcomes (3)
Patient Comfort
Measured: Days 1-4
Patient Satisfaction
Measured: Day 5
Treatment Preference
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJan 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652496
- Sponsor's protocol ID
- 192024-030
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 3 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00652496
- Acronym / sponsor ID
- 192024-030
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 3 Apr 2008 (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.
This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bimatoprost 0.01% ophthalmic solutionBimatoprost 0.01% ophthalmic solution |
| 2 | Experimental | Drug: Bimatoprost 0.015% formulation 1 ophthalmic solutionBimatoprost 0.015% formulation 1 ophthalmic solution |
| 3 | Experimental | Drug: Bimatoprost 0.015% formulation 2 ophthalmic solutionBimatoprost 0.015% formulation 2 ophthalmic solution |
| 4 | Experimental | Drug: Bimatoprost 0.02% ophthalmic solutionBimatoprost 0.02% ophthalmic solution |
| 5 | Active comparator | Drug: Bimatoprost 0.03% ophthalmic solutionBimatoprost 0.03% ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ocular hypertension or glaucoma in both eyes
- Require IOP-lowering therapy in each eye
Key exclusion criteria (2 listed)
- Uncontrolled systemic disease
- Known allergy or hypersensitivity to bimatoprost
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% ophthalmic solutionOne drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop | Drug | 1 |
| Bimatoprost 0.015% formulation 1 ophthalmic solutionOne drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop | Drug | 2 |
| Bimatoprost 0.015% formulation 2 ophthalmic solutionOne drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop | Drug | 3 |
| Bimatoprost 0.02% ophthalmic solutionOne drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop | Drug | 4 |
| Bimatoprost 0.03% ophthalmic solutionAlso: LUMIGAN®Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs | Drug | 5 |
Primary outcome
Intraocular pressure (IOP)
Time frame: Day 5
3 secondary outcomes
Patient Comfort
Time frame: Days 1-4
Patient Satisfaction
Time frame: Day 5
Treatment Preference
Time frame: Day 5
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 3 Apr 2008.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimatoprost 0.01% ophthalmic solution, Bimatoprost 0.015% formulation 1 ophthalmic solution and Bimatoprost 0.015% formulation 2 ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Allergan at 1 site 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 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 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Intraocular pressure (IOP) (time frame: Day 5). 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 3 Apr 2008.