Glaucoma, Open-AnglePhase 2NCT00824720
Safety and Efficacy of a Glaucoma Drug Delivery System
A Phase 2 study testing High Dose Device and Low Dose Device in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Vistakon Pharmaceuticals at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma 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
- Glaucoma, Open-Angle, Ocular Hypertension
- What is being tested?
- High Dose Device and Low Dose Device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2008to Apr 2009
- 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
- must have 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
4 sites in 1 country.
United States4 sites
Study site
Artesia, California
Study site
Baltimore, Maryland, USA
Study site
Louisville, Kentucky
Study site
Mt. Pleasant, South Carolina
About this study
The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Being tested
- High Dose Device, Low Dose Device, Placebo Device
- 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 DeviceDrug
inserted for 14 days
Low Dose DeviceDrug
inserted for 14 days
Placebo DeviceDevice
inserted for 14 days
| Study group | Role | What they receive |
|---|---|---|
| High Dose Device | Experimental | device worn continuously for 14 days Receives: Drug: High Dose Device |
| Low Dose Device | Experimental | device worn continuously for 14 days Receives: Drug: Low Dose Device |
| Placebo Device | Placebo comparator | device worn continuously for 14 days Receives: Device: Placebo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity - Right Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: at 14 days
Visual Acuity - Left Eye
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: at 14 days
Secondary outcomes (1)
Intraocular Pressure (IOP)
Measured: from baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionApr 2009
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 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
- NCT00824720
- Sponsor's protocol ID
- CR-1630
- Status last verified
- Feb 2015
- First submitted
- 9 Jan 2009
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
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 Glaucoma Drug Delivery System
- ClinicalTrials.gov ID
- NCT00824720
- Acronym / sponsor ID
- CR-1630
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Posted 14 May 2010
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 evaluate the ocular safety and efficacy of a glaucoma 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 Device | Experimental | Drug: High Dose Devicedevice worn continuously for 14 days |
| Low Dose Device | Experimental | Drug: Low Dose Devicedevice worn continuously for 14 days |
| Placebo Device | Placebo comparator | Device: Placebo Devicedevice worn continuously for 14 days |
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
- must have 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 Deviceinserted for 14 days | Drug | High Dose Device |
| Low Dose Deviceinserted for 14 days | Drug | Low Dose Device |
| Placebo Deviceinserted for 14 days | Device | Placebo Device |
Primary outcome
Visual Acuity - Right Eye
Time frame: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Visual Acuity - Left Eye
Time frame: at 14 days
This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
1 secondary outcome
Intraocular Pressure (IOP)
Time frame: from baseline to 14 days
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.
4 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 Device and Low Dose Device in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Vistakon Pharmaceuticals at 4 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 4 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. Some participants in this study may receive a placebo. 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 14 May 2010). 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?
Visual Acuity - Right Eye (time frame: at 14 days). The study lists 2 primary outcomes in all. 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.