Ocular HypertensionPhase 2NCT02014142
A Phase 2 Single-Masked, Randomized Study of Latanoprost PPDS in Ocular Hypertension or Open-Angle Glaucoma
A Phase 2 study testing Latanoprost Punctal Plug Delivery System (L-PPDS) in people with Ocular Hypertension and Open-Angle Glaucoma, run by Mati Therapeutics Inc. at 18 sites in United States.
Trial summary
Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS placement on efficacy will also be examined. 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 (L-PPDS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 18 sitesUnited States
- Study dates
- Dec 2013to Dec 2016
- 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, 18 years or older at the time of the screening examination
- Subject diagnosed with bilateral OAG or OH
- Subject IOP is currently controlled (< 21 mmHg) with a topical prostaglandin or in conjunction with one other topical ocular hypotensive drug, not including any fixed-combination formulations (i.e., Cosopt, Combigan, Azarga, etc.) for at least one month or more
- Subject who has lower and upper puncta > 0.5 mm and < 0.9 mm (pre-dilation) in both eyes
- Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
- Subject must be willing to comply with study instructions, dosing (if applicable), agree to make all office appointments, and complete the entire course of the study
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- Women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control, including intrauterine device (IUD); oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; or barrier methods with spermicide
- Subject has a central corneal thickness of > 500 μm and < 600 μm in study eye
- Subject has a BCVA or pinhole visual acuity (Snellen) of 20/100 or better in both eyes
Who cannot join
- Subject with a history of non-response to topical prostaglandin eye drops for OAG/OH
- Subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
- Subject with a known sensitivity to latanoprost, timolol, fluorescein, topical anesthetic, silicone, any inactive ingredient of the L-PPDS or any other products required for the study procedures
- Subject with a history of intolerance to topical beta-blocker therapy
- Subject with > 0.8 vertical cup or completely notched optic nerve head rim in either eye
- Subject with any functionally significant visual field loss or progressive field loss within the last year in either eye
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- Subject with a history of complications, AEs, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in study eye
- Subject with structural lid abnormalities (i.e., ectropion, entropion) in study eye
- Subject with an active lid disease in either eye (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment
- Subject with a history of chronic/recurrent inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye
- Subject who would require the use of any ocular topical medication(s), an over-the counter drop(s), ointment(s) or gel(s), other than the study ocular hypotensive medication(s) in either eye during the study period
- Subject who has had any ophthalmic surgical procedures (i.e., glaucoma laser, minimally invasive glaucoma surgery, cataract, refractive, etc.) in study eye within the last six months or will require ophthalmic surgery before completing the study
- Subject with a history of penetrating keratoplasty in study eye
- Subject who is incapable of instilling ocular drops into his or her eyes
- Subject requiring the use of a contact lens in either eye at any time during the study period
- Subject with advanced diabetic retinopathy, branch retinal vein occlusion or central retinal vein occlusion in either eye
- Subject with a history of macular edema in either eye
- Subject currently on any systemic medication [i.e., beta-blocker, carbonic anhydrase inhibitors, corticosteroids (including dermal), etc.], that may have an effect on the subject's IOP, or who will require its use during the study period (Note: an inhaled steroid, systemic beta-blocker or β-adrenoceptor antagonist may be permitted, providing the subject has maintained a stable dosage regimen for at least the last three months)
- Subject contraindicated to therapy with a beta-blocker (i.e., history or presence of bradycardia, untreated congestive heart failure, untreated second- or third-degree heart block, sino-atrial block, myasthenia gravis, cardiogenic shock, history or presence of bronchial asthma, bronchial hyperreactivity, severe chronic obstructive pulmonary disease, or history of bronchospasm)
- Subject with an uncontrolled systemic disease or a medical condition that may increase the risk associated with study participation or administration of study treatment or that may interfere with the interpretation of study results (e.g., autoimmune disease if the subject is on chronic medications and has ocular involvement; host-versus-graft disease)
- Subject currently participating or has participated within the last 30 days prior to the start of this study in a drug, device or other investigational research study
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Chu Vision Institute
Bloomington, Minnesota, 55420
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, 33904
Arizona Eye Center
Chandler, Arizona, 85225
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Indiana Universtiy - Eugene and Marilyn Glick Eye Institute Ophthalmology Center
Indianapolis, Indiana, 46202
Abrams Eye Institute
Las Vegas, Nevada, 89148
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
University Eye Surgeons
Maryville, Tennessee, 37803
Total Eye Care
Memphis, Tennessee, 38119
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Wills Eye Hospital
Phildelphia, Pennsylvania, 19107
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
Dr. Steven T. Simmons
Slingerlands, New York, 12159
Ophthalmology Associates
St Louis, Missouri, 63131
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090
About this study
Official title: A Phase 2 Single-Masked, Randomized Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS placement on efficacy will also be examined.
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Being tested
- Latanoprost Punctal Plug Delivery System (L-PPDS)
- 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 System (L-PPDS)Drug
Latanoprost Punctal Plug Delivery System (L-PPDS)
| Study group | Role | What they receive |
|---|---|---|
| Group A. L-PPDS single occlusion | Experimental | Latanoprost Punctal Plug Delivery System (L-PPDS) continuous single occlusion; L-PPDS will be inserted in the lower punctum and no plug will be inserted in the upper punctum of each eye; L-PPDS will remain for a period of 14 weeks. Receives: Drug: Latanoprost Punctal Plug Delivery System (L-PPDS) |
| Group B. L-PPDS double occlusion | Experimental | Latanoprost Punctal Plug Delivery System (L-PPDS) continuous double occlusion; L-PPDS will be inserted in the lower punctum and non-therapeutic (NT) plug will be inserted in the upper punctum of each eye and both will remain for a period of 14 weeks. Receives: Drug: Latanoprost Punctal Plug Delivery System (L-PPDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP change from baseline and the primary analysis time point will be the IOP assessment at Week 12
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 posted18 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 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
- NCT02014142
- Sponsor's protocol ID
- PPL GLAU M1
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Single-Masked, Randomized Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02014142
- Acronym / sponsor ID
- PPL GLAU M1
- Conditions
- Ocular Hypertension, Open-Angle Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Dec 2013 (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.
Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS placement on efficacy will also be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A. L-PPDS single occlusion | Experimental | Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)Latanoprost Punctal Plug Delivery System (L-PPDS) continuous single occlusion; L-PPDS will be inserted in the lower punctum and no plug will be inserted in the upper punctum of each eye; L-PPDS will remain for a period of 14 weeks. |
| Group B. L-PPDS double occlusion | Experimental | Drug: Latanoprost Punctal Plug Delivery System (L-PPDS)Latanoprost Punctal Plug Delivery System (L-PPDS) continuous double occlusion; L-PPDS will be inserted in the lower punctum and non-therapeutic (NT) plug will be inserted in the upper punctum of each eye and both will remain for a period of 14 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 18 years or older at the time of the screening examination
- Subject diagnosed with bilateral OAG or OH
- Subject IOP is currently controlled (< 21 mmHg) with a topical prostaglandin or in conjunction with one other topical ocular hypotensive drug, not including any fixed-combination formulations (i.e., Cosopt, Combigan, Azarga, etc.) for at least one month or more
- Subject who has lower and upper puncta > 0.5 mm and < 0.9 mm (pre-dilation) in both eyes
- Subject must be able and willing to read, comprehend and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent
Key exclusion criteria (21 listed)
- Subject with a history of non-response to topical prostaglandin eye drops for OAG/OH
- Subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or iridocorneal endothelium syndrome in either eye
- Subject with a known sensitivity to latanoprost, timolol, fluorescein, topical anesthetic, silicone, any inactive ingredient of the L-PPDS or any other products required for the study procedures
- Subject with a history of intolerance to topical beta-blocker therapy
- Subject with > 0.8 vertical cup or completely notched optic nerve head rim in either eye
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 System (L-PPDS)Latanoprost Punctal Plug Delivery System (L-PPDS) | Drug | Group A. L-PPDS single occlusion, Group B. L-PPDS double occlusion |
Primary outcome
IOP change from baseline and the primary analysis time point will be the IOP assessment at Week 12
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 18 Jan 2017.
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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.
18 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 Punctal Plug Delivery System (L-PPDS) in people with Ocular Hypertension and Open-Angle Glaucoma, run by Mati Therapeutics Inc. at 18 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 9 inclusion and 21 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 and the primary analysis time point will be the IOP assessment at Week 12 (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 18 Jan 2017.