GlaucomaPhase 2CORENCT00650702
Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 2 study testing Latanoprost-PPDS in people with Glaucoma and Ocular Hypertension, run by Mati Therapeutics Inc. at 8 sites in United States.
Trial summary
The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 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?
- Latanoprost-PPDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2008to Feb 2009
- 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
- Over 18 yrs with open-angle glaucoma or ocular hypertension
- Subjects who have a best-corrected visual acuity of 20/100 or better.
Who cannot join
- Uncontrolled medical conditions.
- Subjects who wear contact lenses.
- Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
- Subjects who have a history of chronic or recurrent inflammatory eye disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Artesia, California, 90701
Study site
Bel Air, Maryland, 21014
Study site
High Point, North Carolina, 27262
Study site
Lynbrook, New York, 11563
Study site
Minneapolis, Minnesota, 55404
Study site
Philadelphia, Pennsylvania, 19148
Study site
Sacramento, California, 95815
Study site
St Louis, Missouri, 63131
About this study
Official title: A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Latanoprost-PPDS
- Keywords
- glaucoma, ocular hypertension, IOP
- 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.
Latanoprost-PPDSDrug
Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Latanoprost-PPDSDrug
Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
Latanoprost-PPDSDrug
Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low Latanoprost-PPDS Receives: Drug: Latanoprost-PPDS |
| 2 | Experimental | Medium Latanoprost-PPDS Receives: Drug: Latanoprost-PPDS |
| 3 | Experimental | High Latanoprost-PPDS Receives: Drug: Latanoprost-PPDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP change from baseline
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650702
- Sponsor's protocol ID
- PPL GLAU 02
- Acronym
- CORE
- Status last verified
- Mar 2011
- First submitted
- 27 Mar 2008
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00650702
- Acronym / sponsor ID
- CORE / PPL GLAU 02
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma, ocular hypertension, IOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 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.
The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Latanoprost-PPDSLow Latanoprost-PPDS |
| 2 | Experimental | Drug: Latanoprost-PPDSMedium Latanoprost-PPDS |
| 3 | Experimental | Drug: Latanoprost-PPDSHigh Latanoprost-PPDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 yrs with open-angle glaucoma or ocular hypertension
- Subjects who have a best-corrected visual acuity of 20/100 or better.
Key exclusion criteria (4 listed)
- Uncontrolled medical conditions.
- Subjects who wear contact lenses.
- Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
- Subjects who have a history of chronic or recurrent inflammatory eye disease.
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 |
|---|---|---|
| Latanoprost-PPDSControl of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy | Drug | 1 |
| Latanoprost-PPDSControl of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy | Drug | 2 |
| Latanoprost-PPDSControl of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy | Drug | 3 |
Primary outcome
IOP change from baseline
Time frame: 12 Weeks
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 19 Sep 2013.
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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.
8 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 Latanoprost-PPDS in people with Glaucoma and Ocular Hypertension, run by Mati Therapeutics Inc. at 8 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 2 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 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
IOP change from baseline (time frame: 12 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 19 Sep 2013.