GlaucomaPhase 2NCT02466399
POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma
A Phase 2 study testing POLAT-001 and Latanoprost ophthalmic solution in people with Glaucoma, run by Peregrine Ophthalmic at 1 site in United States.
Trial summary
This is an open-label, randomized, multi-center, active-controlled parallel-comparison of POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- POLAT-001 and Latanoprost ophthalmic solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year of age or greater.
- Diagnosis of primary open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) intraocular pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days apart. If both eyes meet the IOP criteria, the eye with the higher IOP at Visit 1 will be designated as the study eye. If IOP in both eyes is the same, the right eye will be designated as the study eye. Note that both eyes will be treated.
- Corrected visual acuity at Visit -1 in each eye +1.0 logarithm of minimum angle of resolution (logMAR) or better by Early Treatment of Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
- Subjects must have a documented history of ≥ 20% IOP reduction O.U. using any topical ocular prostaglandin/prostamide ocular hypotensive medication.
Who cannot join
- Ophthalmic
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles judged to be occludable by the investigator. Note: Previous laser peripheral iridotomy is NOT acceptable.
- IOP > 36 mm Hg in either eye at any pre-randomization study visit.
- Known corticosteroid-responder as judged by investigator.
- Known hypersensitivity to any component of the Investigational Product formulation (benzalkonium chloride, etc.), fluoroquinolone ophthalmic solution, or topical anesthetics, Povidone Iodine antiseptic, or diagnostic eye drops.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
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- Refractive surgery in either eye .
- Ocular trauma, extraocular or intraocular surgery or laser treatment within the past six months in either eye.
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis in either eye. Note: mild blepharitis, allergy and dry eye is acceptable.
- Ocular medication of any kind within 30 days of Visit 1 in either eye, with the exception of a) ocular hypotensive therapy (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
- Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis sicca) in either eye which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe by the investigator (i.e., cup-disc ratio > 0.8).
- Central corneal thickness greater than 600 µm in either eye.
- Any ocular abnormality preventing reliable applanation tonometry of either eye.
- Significant media opacity in either eye that would exclude adequate posterior segment examination
- Contraindications to pupil dilation in either eye.
- Unwillingness to accept known adverse events of latanoprost such as eyelid and/or iris pigmentation, eyelash growth, etc.
- History of macular edema, including cystoid macular edema, or current or recent (6 months) uveitis.
- Planned intraocular surgery in either eye during study participation
- Systemic:
- Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
- Known hypersensitivity or systemic contraindication to latanoprost or components of study medication.
- Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders), which might interfere with the study.
- Participation in any investigational study within 30 days prior to baseline.
- Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
- Any individual the investigator believes might suffer physical or mental harm by participating in this trial. Due to the current status of the preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the Visit 1 examination and must agree to use an acceptable method of contraception during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Professional Research Network
Goose Creek, South Carolina, 29445
About this study
Official title: An Open-label Comparison of the Safety and Efficacy of Subconjunctival Liposomal Latanoprost (POLAT-001) to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Primary Open Angle Glaucoma
This is an open-label, randomized, multi-center, active-controlled parallel-comparison of POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary open-angle glaucoma.
- Conditions
- Glaucoma
- Being tested
- POLAT-001, Latanoprost ophthalmic solution
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLAT-001Drug
Subconjunctival injection
Latanoprost ophthalmic solutionDrug
Latanoprost ophthalmic solution q.d., evening
| Study group | Role | What they receive |
|---|---|---|
| POLAT-001 | Experimental | Latanoprost liposome ophthalmic injection Receives: Drug: POLAT-001 |
| Latanoprost ophthalmic solution | Active comparator | latanoprost ophthalmic solution 0.005% Receives: Drug: Latanoprost ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months
The mean change from baseline intraocular pressure at 3 months (0800 hrs)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peregrine Ophthalmic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina T Wong, MD, Ph.D., Study director, Peregrine Ophthalmic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466399
- Sponsor's protocol ID
- LipoLat-CS202
- Status last verified
- Sep 2020
- First submitted
- 27 May 2015
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Comparison of the Safety and Efficacy of Subconjunctival Liposomal Latanoprost (POLAT-001) to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02466399
- Acronym / sponsor ID
- LipoLat-CS202
- Conditions
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peregrine OphthalmicIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, multi-center, active-controlled parallel-comparison of POLAT-001 to latanoprost ophthalmic solution in patients with ocular hypertension and primary open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POLAT-001 | Experimental | Drug: POLAT-001Latanoprost liposome ophthalmic injection |
| Latanoprost ophthalmic solution | Active comparator | Drug: Latanoprost ophthalmic solutionlatanoprost ophthalmic solution 0.005% |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 year of age or greater.
- Diagnosis of primary open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) intraocular pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days apart. If both eyes meet the IOP criteria, the eye with the higher IOP at Visit 1 will be designated as the study eye. If IOP in both eyes is the same, the right eye will be designated as the study eye. Note that both eyes will be treated.
- Corrected visual acuity at Visit -1 in each eye +1.0 logarithm of minimum angle of resolution (logMAR) or better by Early Treatment of Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
Key exclusion criteria (25 listed)
- Ophthalmic
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles judged to be occludable by the investigator. Note: Previous laser peripheral iridotomy is NOT acceptable.
- IOP > 36 mm Hg in either eye at any pre-randomization study visit.
- Known corticosteroid-responder as judged by investigator.
- Known hypersensitivity to any component of the Investigational Product formulation (benzalkonium chloride, etc.), fluoroquinolone ophthalmic solution, or topical anesthetics, Povidone Iodine antiseptic, or diagnostic eye drops.
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 |
|---|---|---|
| POLAT-001Subconjunctival injection | Drug | POLAT-001 |
| Latanoprost ophthalmic solutionLatanoprost ophthalmic solution q.d., evening | Drug | Latanoprost ophthalmic solution |
Primary outcome
Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months
Time frame: 3 months
The mean change from baseline intraocular pressure at 3 months (0800 hrs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tina T Wong, MD, Ph.D. study director
Peregrine Ophthalmic
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 POLAT-001 and Latanoprost ophthalmic solution in people with Glaucoma, run by Peregrine Ophthalmic 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 6 inclusion and 25 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 16 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months (time frame: 3 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 16 Nov 2020.