GlaucomaPhase 2NCT01481077
A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
A Phase 2 study testing Latanoprost-PPDS in people with Glaucoma and Ocular Hypertension (OH), run by Mati Therapeutics Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension (OH)
- What is being tested?
- Latanoprost-PPDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2011to Sep 2012
- 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
- Male or female at least 18 years old
- Diagnosis of bilateral open angle glaucoma or ocular hypertension
- Unmedicated IOP must be ≥22mm Hg
Who cannot join
- Any significant vision loss in the last year
- No contact lens use for the length of the study
- Abnormal eye lids, eye infection or diseases to the eye
- Recent eye surgery
- Uncontrolled medical conditions
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810
Glaucoma Consultants of Colorado, PC
Denver, Colorado, 80134
Ophthalmology Consultants Inc.
Des Peres, Missouri, 63131
Las Vegas Physicians Research Group
Henderson, Nevada, 89052
Abrams Eye Institute
Las Vegas, Nevada, 89148
University Eye Surgeons
Maryville, Tennessee, 37803
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Vold Vision
Springdale, Arkansas, 72762
Ophthalmology Associates
St Louis, Missouri, 63131
Comprehensive Eye Care, Ltd
Washington, Missouri, 63090
About this study
Official title: PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety 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 determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).
- Conditions
- Glaucoma, Ocular Hypertension (OH)
- 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
Sustained release for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Latanoprost-PPDS |
| Treatment B | Experimental | Not described Receives: Drug: Latanoprost-PPDS |
| Treatment C | 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: 12 weeks to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suzanne Cadden, Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481077
- Sponsor's protocol ID
- PPL GLAU 13
- Status last verified
- Sep 2013
- First submitted
- 25 Nov 2011
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPL GLAU 13: A Randomized Phase 2 Study of the Effect of Plug Placement on Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT01481077
- Acronym / sponsor ID
- PPL GLAU 13
- Conditions
- Glaucoma, Ocular Hypertension (OH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Nov 2011 (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 the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Latanoprost-PPDS |
| Treatment B | Experimental | Drug: Latanoprost-PPDS |
| Treatment C | 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 (3 listed)
- Male or female at least 18 years old
- Diagnosis of bilateral open angle glaucoma or ocular hypertension
- Unmedicated IOP must be ≥22mm Hg
Key exclusion criteria (5 listed)
- Any significant vision loss in the last year
- No contact lens use for the length of the study
- Abnormal eye lids, eye infection or diseases to the eye
- Recent eye surgery
- Uncontrolled medical conditions
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-PPDSSustained release for 12 weeks | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
IOP change from baseline
Time frame: 12 weeks to baseline
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 26 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.
Suzanne Cadden study director
QLT Inc.
11 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 (OH), run by Mati Therapeutics Inc. at 11 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 5 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 26 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 11 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 to baseline). 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 26 Sep 2013.