GlaucomaPhase 2NCT00967811
A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG
A Phase 2 study testing Formulation E1 of L-PPDS and Formulation E2 of L-PPDS in people with Glaucoma and Ocular Hypertension, run by Mati Therapeutics Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the 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?
- Formulation E1 of L-PPDS and Formulation E2 of L-PPDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 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
- Subjects over 18 years of age diagnosed 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
- Subjects who have uncontrolled medical conditions
- Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications
- Subjects who have a history of chronic or recurrent inflammatory eye disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) 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 the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Formulation E1 of L-PPDS, Formulation E2 of L-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.
Formulation E1 of L-PPDSDrug
Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
Formulation E2 of L-PPDSDrug
Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
| Study group | Role | What they receive |
|---|---|---|
| 1. Formulation E1 | Experimental | Formulation E1 of Latanoprost-PPDS Receives: Drug: Formulation E1 of L-PPDS |
| 2. Formulation E2 | Experimental | Formulation E2 of Latanoprost-PPDS Receives: Drug: Formulation E2 of L-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 posted28 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2010
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 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
- NCT00967811
- Sponsor's protocol ID
- PPL GLAU 07
- Status last verified
- Sep 2013
- First submitted
- 27 Aug 2009
- 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
- An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
- ClinicalTrials.gov ID
- NCT00967811
- Acronym / sponsor ID
- PPL GLAU 07
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Aug 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 the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Formulation E1 | Experimental | Drug: Formulation E1 of L-PPDSFormulation E1 of Latanoprost-PPDS |
| 2. Formulation E2 | Experimental | Drug: Formulation E2 of L-PPDSFormulation E2 of 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)
- Subjects over 18 years of age diagnosed 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
- Subjects who have uncontrolled medical conditions
- Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular 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 |
|---|---|---|
| Formulation E1 of L-PPDSControl of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy. | Drug | 1. Formulation E1 |
| Formulation E2 of L-PPDSControl of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy. | Drug | 2. Formulation E2 |
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.
Oscar Cuzzani, MD 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 Formulation E1 of L-PPDS and Formulation E2 of L-PPDS in people with Glaucoma and Ocular Hypertension, 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 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 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?
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.