GlaucomaPhase 2NCT00855517
A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma
A Phase 2 study testing Latanoprost-PPDS in people with Glaucoma and Ocular Hypertension, run by Mati Therapeutics Inc..
Trial summary
The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jul 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 of age with ocular hypertension or open-angle glaucoma
- Subjects who have a best corrected visual acuity of 20/100 or better
Who cannot join
- Subjects who wear contact lenses.
- Uncontrolled medical conditions
- Subjects requiring chronic topical artifical tears, lubricants and/or requiring any other chronic topical medications
- Subjects who have a history of chronic or recurrent inflammatory eye disease
About this study
Official title: A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Latanoprost-PPDS
- 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 experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Punctal Plug | Experimental | Not described 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: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: Sponsor's decision
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oscar Cuzzani, MD, Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855517
- Sponsor's protocol ID
- PPL GLAU 06
- Status last verified
- Sep 2013
- First submitted
- 2 Mar 2009
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT00855517
- Acronym / sponsor ID
- PPL GLAU 06
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Mar 2009 (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 evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Punctal Plug | Experimental | Drug: 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 of age with ocular hypertension or open-angle glaucoma
- Subjects who have a best corrected visual acuity of 20/100 or better
Key exclusion criteria (4 listed)
- Subjects who wear contact lenses.
- Uncontrolled medical conditions
- Subjects requiring chronic topical artifical 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 experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy. | Drug | Punctal Plug |
Primary outcome
IOP change from baseline
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
Oscar Cuzzani, MD study director
QLT Inc.
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..
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: withdrawn, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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: 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 17 Sep 2013.