Primary Open Angle Glaucoma (POAG)Phase 1Latanoprost SRNCT01180062
Safety Study of Latanoprost Slow Release Insert
A Phase 1 study testing Latanoprost, Arm 2 and Latanoprost SR insert in people with Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Daniel Moore at 1 site in United States.
Trial summary
This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which will be conducted at one study site. This study will include 3 cohorts. Each cohort will have approximately 5 subjects. Subjects will not be randomized into the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
- What is being tested?
- Latanoprost, Arm 2 and Latanoprost SR insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2014
- Phase
- Phase 1
- 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 and female POAG and OHT subjects who are well controlled on mono therapy or dual therapy, who have not undergone any prior glaucoma surgeries and are not allergic or non-responders to any prostaglandin analogues, will be included in this study.
- At least 18 years old at time of consent.
- Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative glaucoma patients) or ocular hypertension in 1 or both eyes.
- IOP deemed as well controlled by investigators, with prostaglandin analogue/ prostanoid either as a monotherapy or part of dual medical therapy.
- Subjects with mild or moderate glaucoma where subjects can be without IOP lowering treatment for up to 2 months.
- Mean IOP of at least 22 mmHg in the study eye and not more than 36 mmHg in either eye at 8 AM on the baseline visit (after 4 weeks of washout).
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- Mean IOP of at least 20 mmHg in the same eye that qualified at 8 AM and not more than 36 mmHg in either eye at 10 AM, 12 PM, 2 PM and 4 PM on baseline visit.
- Best Corrected Visual Acuity of 20/100 or better by Snellen's visual acuity measurement in each eye (or equivalent ETDRS Visual acuity).
- Clear ocular media with good view of optic disc and macula.
- Negative urine pregnancy test at baseline for women of childbearing potential.
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Closed/barely open anterior chamber angle or a history of acute angle closure (i.e., 75% of the circumference of the angle is 10° or less) in either eye.
- Subjects with diagnosis of secondary glaucoma.
- Diagnosis of a clinically significant or progressive retinal disease (e.g. diabetic retinopathy, macular degeneration) in either eye that would inhibit accurate VA testing.
- Advanced glaucoma defined by a cup/disc ratio >0.8 or a history of severe central visual field loss in either eye.
- History of intolerance and or lack of response to prostaglandin analogues.
- History of hypersensitivity to latanoprost or any other ingredient in the study drug.
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- Central corneal thickness greater than 600 μm in either eye.
- Any condition that prevents reliable applanation tonometry (e.g. significant abnormalities of the corneal surface) in either eye.
- History of severe dry eye.
- Eye lid abnormalities i.e. entropion, ectropion or lower lid retraction.
- Evidence of corneal punctate staining, exposure keratopathy or keratitis, history of infectious keratitis i.e. herpes.
- History of ocular cicatricial diseases i.e. cicatricial pemphigoid, pemphigus, S-J syndrome, conjunctival scarring secondary to topical medications.
- History of endothelial dystrophy (Fuchs, corneal guttata) or corneal edema.
- History of iritis or uveitis.
- History of clinically significant aspirin intolerant asthma (AIA).
- History of any ocular surgery or trauma in either eye within 3 months of the screening visit.
- History of glaucoma filtration surgery including but not limited to Trabeculectomy, Canaloplasty, Trabectome and Glaucoma Drain surgery.
- History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
- Unable to discontinue contact lens use.
- Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect IOP during the study period.
- Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the patient inappropriate for entry into this study.
- Treatment with an investigational drug or device within 30 days preceding the device placement.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication and throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Ky Dept of Ophthalmology and Visual Sciences
Lexington, Kentucky, 40546
About this study
Official title: A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety and Tolerability of Latanoprost Sustained Release (SR) Insert in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which will be conducted at one study site. This study will include 3 cohorts. Each cohort will have approximately 5 subjects. Subjects will not be randomized into the study. The first cohort will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus achieving twice the drug levels compared to cohort I and third cohort will receive high dose drug insert.
Read the detailed description
The purpose of this study is to determine the tolerability and safety of the biodegradable extended release Latanoprost subconjunctival insert for primary open angle glaucoma (POAG) and ocular hypertension (OHT) patients. Intraocular pressure lowering ability of biodegradable extended release Latanoprost subconjunctival insert in POAG and OHT patients will also be evaluated.
Low dose inserts have an initial release rate of approximately 1 µg/day slowing to 0.2 µg/day after approximately 10 days; this release rate is maintained. High dose inserts have an initial release of approximately 4 µg/day, which slows to approximately 1 ug/day after 10 days. Each drop of Xalatan (the commercial form of latanoprost) contains approximately 1 µg of latanoprost. The first cohort will receive inserts that initially provide the same dose as is administered topically before their release rate slows down to a lower dose. The inserts used in this study are composed of a drug core in a (Poly Lactic Glycolic acid) PLGA polymer tube. One end of the tube is capped with an impermeable polymer (silicone) and the other end with a permeable polymer (Polyvinyl alcohol). Drug release occurs across the permeable end and is a function of internal diameter of the tube. Low dose insert and high dose insert are exactly the same except that for low dose inserts the internal diameter of the PLGA tubes is smaller. Thus different release rates (and drug loading) are obtained with the same formulation. Inserts are designed to provide steady state release for 3-6 months.
- Being tested
- Latanoprost, Arm 2, Latanoprost SR insert
- Keywords
- Latanoprost subconjunctival insert
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Also called Xalatan
Group 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost.
Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.
Duration of drug release is expected to be 3-6 months.
Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.
Arm 2Drug
Also called Xalatan
Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.
Latanoprost SR insertDrug
Also called Xalatan
Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Group 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost. Receives: Drug: Latanoprost |
| Active Comparator - Arm 2 | Active comparator | Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost. Receives: Drug: Latanoprost; Drug: Arm 2 |
| Active Comparator - Arm 3 | Active comparator | Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost. Receives: Drug: Latanoprost; Drug: Latanoprost SR insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
- Local reaction around the insert site including swelling, hyperemia, scarring, erosion, infection in the study eye
- Hyperemia grading for both eyes
- Discomfort and tolerability scale
- Occurrence of iritis/uveitis in the study eye
- Detection of macular thickening/edema in the study eye
Measured: 12 months
Secondary outcomes (1)
Intraocular pressure parameters i.e. mean IOP, IOP range, percentage reduction in IOP, IOP fluctuation.
Intraocular pressure parameters i.e. mean IOP, IOP range, percentage reduction in IOP, IOP fluctuation will be analyzed for visits at 2 week and months 1, 2 and 3. Monthly IOP monitoring will be continued past 3 months up to 9 months in subjects who continue to have IOP lowering and are not switched back to baseline topical therapy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Study terminated early due to manufacturer not replenishing study site supply of inserts, despite repeated requests for more inserts.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Moore
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Daniel Moore, University of Kentucky
- Investigators
- Daniel B. Moore, M.D., Principal investigator, Univ of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180062
- Sponsor's protocol ID
- 10-0476-F1V
- Other IDs
- IND# 109,182
- Acronym
- Latanoprost SR
- Status last verified
- Dec 2014
- First submitted
- 10 Aug 2010
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Escalation Study to Evaluate the Safety and Tolerability of Latanoprost Sustained Release (SR) Insert in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
- ClinicalTrials.gov ID
- NCT01180062
- Acronym / sponsor ID
- Latanoprost SR / 10-0476-F1V
- Keywords
- Latanoprost subconjunctival insert
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to manufacturer not replenishing study site supply of inserts, despite repeated requests for more inserts.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Daniel MooreUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Aug 2010 (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.
This study is a phase 1, open-label, dose-escalation, safety and tolerability study, which will be conducted at one study site. This study will include 3 cohorts. Each cohort will have approximately 5 subjects. Subjects will not be randomized into the study. The first cohort will receive low dose drug insert, second cohort will receive 2 low dose drug inserts thus achieving twice the drug levels compared to cohort I and third cohort will receive high dose drug insert.
Detailed description
The purpose of this study is to determine the tolerability and safety of the biodegradable extended release Latanoprost subconjunctival insert for primary open angle glaucoma (POAG) and ocular hypertension (OHT) patients. Intraocular pressure lowering ability of biodegradable extended release Latanoprost subconjunctival insert in POAG and OHT patients will also be evaluated.
Low dose inserts have an initial release rate of approximately 1 µg/day slowing to 0.2 µg/day after approximately 10 days; this release rate is maintained. High dose inserts have an initial release of approximately 4 µg/day, which slows to approximately 1 ug/day after 10 days. Each drop of Xalatan (the commercial form of latanoprost) contains approximately 1 µg of latanoprost. The first cohort will receive inserts that initially provide the same dose as is administered topically before their release rate slows down to a lower dose. The inserts used in this study are composed of a drug core in a (Poly Lactic Glycolic acid) PLGA polymer tube. One end of the tube is capped with an impermeable polymer (silicone) and the other end with a permeable polymer (Polyvinyl alcohol). Drug release occurs across the permeable end and is a function of internal diameter of the tube. Low dose insert and high dose insert are exactly the same except that for low dose inserts the internal diameter of the PLGA tubes is smaller. Thus different release rates (and drug loading) are obtained with the same formulation. Inserts are designed to provide steady state release for 3-6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: LatanoprostGroup 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost. |
| Active Comparator - Arm 2 | Active comparator | Drug: Latanoprost, Drug: Arm 2Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost. |
| Active Comparator - Arm 3 | Active comparator | Drug: Latanoprost, Drug: Latanoprost SR insertGroup 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female POAG and OHT subjects who are well controlled on mono therapy or dual therapy, who have not undergone any prior glaucoma surgeries and are not allergic or non-responders to any prostaglandin analogues, will be included in this study.
- At least 18 years old at time of consent.
- Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative glaucoma patients) or ocular hypertension in 1 or both eyes.
- IOP deemed as well controlled by investigators, with prostaglandin analogue/ prostanoid either as a monotherapy or part of dual medical therapy.
- Subjects with mild or moderate glaucoma where subjects can be without IOP lowering treatment for up to 2 months.
Key exclusion criteria (23 listed)
- Closed/barely open anterior chamber angle or a history of acute angle closure (i.e., 75% of the circumference of the angle is 10° or less) in either eye.
- Subjects with diagnosis of secondary glaucoma.
- Diagnosis of a clinically significant or progressive retinal disease (e.g. diabetic retinopathy, macular degeneration) in either eye that would inhibit accurate VA testing.
- Advanced glaucoma defined by a cup/disc ratio >0.8 or a history of severe central visual field loss in either eye.
- History of intolerance and or lack of response to prostaglandin analogues.
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 |
|---|---|---|
| LatanoprostAlso: XalatanGroup 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost. Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost. Duration of drug release is expected to be 3-6 months. Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost. | Drug | Active Comparator - Arm 2, Active Comparator - Arm 3, Arm 1 |
| Arm 2Also: XalatanGroup 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost. | Drug | Active Comparator - Arm 2 |
| Latanoprost SR insertAlso: XalatanGroup 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost. | Drug | Active Comparator - Arm 3 |
Primary outcome
Intraocular Pressure
Time frame: 12 months
1. Local reaction around the insert site including swelling, hyperemia, scarring, erosion, infection in the study eye 2. Hyperemia grading for both eyes 3. Discomfort and tolerability scale 4. Occurrence of iritis/uveitis in the study eye 5. Detection of macular thickening/edema in the study eye
1 secondary outcome
Intraocular pressure parameters i.e. mean IOP, IOP range, percentage reduction in IOP, IOP fluctuation.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study terminated early due to manufacturer not replenishing study site supply of inserts, despite repeated requests for more inserts.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Daniel B. Moore, M.D. principal investigator
Univ of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Latanoprost, Arm 2 and Latanoprost SR insert in people with Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT), run by Daniel Moore 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 12 inclusion and 23 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: stopped early, as of the sponsor's last update on 8 Dec 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Study terminated early due to manufacturer not replenishing study site supply of inserts, despite repeated requests for more inserts.). Results are not available in the source record.
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?
Intraocular Pressure (time frame: 12 months). 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 8 Dec 2014.