Ocular HypertensionPhase 2NCT01037036
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
A Phase 2 study testing Latanoprost Punctal Plug Delivery System and Xalatan in people with Ocular Hypertension and Open-Angle Glaucoma, run by Mati Therapeutics Inc. at 1 site in United States.
Trial summary
The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open-Angle Glaucoma
- What is being tested?
- Latanoprost Punctal Plug Delivery System and Xalatan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2010
- 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 years
- Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
- Currently on prostaglandin therapy
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Being tested
- Latanoprost Punctal Plug Delivery System, Xalatan
- Keywords
- Ocular Hypertension, Open-Angle Glaucoma, Xalatan, IOP
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost Punctal Plug Delivery SystemDrug
To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.
XalatanDrug
Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost Punctal Plug Delivery System followed by Xalatan | Experimental | Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study. Receives: Drug: Latanoprost Punctal Plug Delivery System; Drug: Xalatan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in IOP measurements
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QLT Inc.
- Responsible party
- Sponsor
- Investigators
- Oscar Cuzanni, MD, MSc, Study director, QLT Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037036
- Sponsor's protocol ID
- PPL GLAU 08
- Status last verified
- Dec 2013
- First submitted
- 17 Dec 2009
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT01037036
- Acronym / sponsor ID
- PPL GLAU 08
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Keywords
- Ocular Hypertension, Open-Angle Glaucoma, Xalatan, IOP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- QLT Inc.
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Dec 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 objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latanoprost Punctal Plug Delivery System followed by Xalatan | Experimental | Drug: Latanoprost Punctal Plug Delivery System, Drug: XalatanSubjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
- Currently on prostaglandin therapy
Key exclusion criteria (3 listed)
- Uncontrolled medical conditions
- Subjects who wear contact lenses
- Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications
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 Punctal Plug Delivery SystemTo evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study. | Drug | Latanoprost Punctal Plug Delivery System followed by Xalatan |
| XalatanSubjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study. | Drug | Latanoprost Punctal Plug Delivery System followed by Xalatan |
Primary outcome
Change from baseline in IOP measurements
Time frame: 4 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 10 Jan 2014.
Related trials for Ocular Hypertension
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
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 Cuzanni, MD, MSc study director
QLT Inc.
1 site 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 Punctal Plug Delivery System and Xalatan in people with Ocular Hypertension and Open-Angle Glaucoma, run by Mati Therapeutics Inc. at 1 site 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 3 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline in IOP measurements (time frame: 4 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 10 Jan 2014.