Open-angle GlaucomaPhase 2NCT01016691
Safety and Efficacy of a Drug Delivery System in Glaucoma
A Phase 2 study testing High Dose Drug Device, Low Dose Drug Device and bimatoprost 0.03% in people with Open-angle Glaucoma and Ocular Hypertension, run by Vistakon Pharmaceuticals at 5 sites in United States.
Trial summary
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- High Dose Drug Device, Low Dose Drug Device and bimatoprost 0.03%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2009to Feb 2010
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman 21 years of age or greater
- Open angle glaucoma or ocular hypertension
- Corrected visual acuity in each eye of 20/200 or better
Who cannot join
- Previous glaucoma intraocular surgery or refractive surgery
- Planned contact lens use during the study
- Clinically significant ocular or systemic disease that might interfere with the study
- Use of chronic corticosteroids by any route
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Maryville, Tennessee
Study site
Miami, Florida
Study site
Mt. Pleasant, South Carolina
Study site
Philadelphia, Pennsylvania
Study site
Rapid City, South Dakota
About this study
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- High Dose Drug Device, Low Dose Drug Device, Placebo Device, bimatoprost 0.03%
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Dose Drug DeviceDrug
device inserted for 4 days
Low Dose Drug DeviceDrug
device inserted for 4 days
Placebo DeviceDrug
device inserted for 4 days
bimatoprost 0.03%Drug
one drop in each eye on one day only
| Study group | Role | What they receive |
|---|---|---|
| High Dose Drug Device/ bimatoprost 0.03% | Experimental | drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). Receives: Drug: High Dose Drug Device; Drug: bimatoprost 0.03% |
| Low Dose Drug Device / bimatoprost 0.03% | Experimental | drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). Receives: Drug: Low Dose Drug Device; Drug: bimatoprost 0.03% |
| Placebo Device / bimatoprost 0.03% | Other | placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). Receives: Drug: Placebo Device; Drug: bimatoprost 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Intraocular Pressure at Day 1
Measured: Baseline to Day 1
Secondary outcomes (4)
Mean Change in Intraocular Pressure at Day 2
Measured: Baseline to Day 2
Mean Change in Intraocular Pressure at Day 3
Measured: Baseline to Day 3
Mean Change in Intraocular Pressure at Day 4
Measured: Baseline to Day 4
Mean Change in Intraocular Pressure at Day 5
Measured: Day 4 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
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 Open-angle 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016691
- Sponsor's protocol ID
- CR-1649
- Status last verified
- Feb 2015
- First submitted
- 18 Nov 2009
- Last updated
- 6 Mar 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 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Drug Delivery System in Glaucoma
- ClinicalTrials.gov ID
- NCT01016691
- Acronym / sponsor ID
- CR-1649
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Posted 27 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose Drug Device/ bimatoprost 0.03% | Experimental | Drug: High Dose Drug Device, Drug: bimatoprost 0.03%drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). |
| Low Dose Drug Device / bimatoprost 0.03% | Experimental | Drug: Low Dose Drug Device, Drug: bimatoprost 0.03%drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). |
| Placebo Device / bimatoprost 0.03% | Other | Drug: Placebo Device, Drug: bimatoprost 0.03%placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or woman 21 years of age or greater
- Open angle glaucoma or ocular hypertension
- Corrected visual acuity in each eye of 20/200 or better
Key exclusion criteria (4 listed)
- Previous glaucoma intraocular surgery or refractive surgery
- Planned contact lens use during the study
- Clinically significant ocular or systemic disease that might interfere with the study
- Use of chronic corticosteroids by any route
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 |
|---|---|---|
| High Dose Drug Devicedevice inserted for 4 days | Drug | High Dose Drug Device/ bimatoprost 0.03% |
| Low Dose Drug Devicedevice inserted for 4 days | Drug | Low Dose Drug Device / bimatoprost 0.03% |
| Placebo Devicedevice inserted for 4 days | Drug | Placebo Device / bimatoprost 0.03% |
| bimatoprost 0.03%one drop in each eye on one day only | Drug | High Dose Drug Device/ bimatoprost 0.03%, Low Dose Drug Device / bimatoprost 0.03%, Placebo Device / bimatoprost 0.03% |
Primary outcome
Mean Change in Intraocular Pressure at Day 1
Time frame: Baseline to Day 1
4 secondary outcomes
Mean Change in Intraocular Pressure at Day 2
Time frame: Baseline to Day 2
Mean Change in Intraocular Pressure at Day 3
Time frame: Baseline to Day 3
Mean Change in Intraocular Pressure at Day 4
Time frame: Baseline to Day 4
Mean Change in Intraocular Pressure at Day 5
Time frame: Day 4 to Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Dose Drug Device, Low Dose Drug Device and bimatoprost 0.03% in people with Open-angle Glaucoma and Ocular Hypertension, run by Vistakon Pharmaceuticals at 5 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 3 inclusion and 4 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 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
Yes. Results are posted in the registry (first posted 27 Jan 2012). 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?
Mean Change in Intraocular Pressure at Day 1 (time frame: Baseline to Day 1). 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 Mar 2015.