- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02466399
POLAT-001 Compared to Latanoprost Ophthalmic Solution in Patients With Ocular Hypertension and Open-angle Glaucoma
October 22, 2020 updated by: Peregrine Ophthalmic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
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Goose Creek, South Carolina, United States, 29445
- Professional Research Network
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: POLAT-001
Latanoprost liposome ophthalmic injection
|
Subconjunctival injection
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Active Comparator: Latanoprost ophthalmic solution
latanoprost ophthalmic solution 0.005%
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Latanoprost ophthalmic solution q.d., evening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tina T Wong, MD, Ph.D., Peregrine Ophthalmic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
May 27, 2015
First Submitted That Met QC Criteria
June 5, 2015
First Posted (Estimate)
June 9, 2015
Study Record Updates
Last Update Posted (Actual)
November 16, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LipoLat-CS202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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