Glaucoma
Conditions
Brief 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.
Interventions
DRUGPOLAT-001
Subconjunctival injection
Latanoprost ophthalmic solution q.d., evening
Sponsors
Peregrine Ophthalmic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. 18 year of age or greater. 2. Diagnosis of primary open angle glaucoma (OAG) or ocular hypertension (OHT). 3. 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. 4. 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). 5. Able and willing to give signed informed consent and follow study instructions. 6. Subjects must have a documented history of ≥ 20% IOP reduction O.U. using any topical ocular prostaglandin/prostamide ocular hypotensive medication.
Exclusion criteria
Ophthalmic 1. 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. 2. IOP \> 36 mm Hg in either eye at any pre-randomization study visit. 3. Known corticosteroid-responder as judged by investigator. 4. 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. 5. Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye. 6. Refractive surgery in either eye . 7. Ocular trauma, extraocular or intraocular surgery or laser treatment within the past six months in either eye. 8. 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. 9. 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). 10. 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). 11. Central corneal thickness greater than 600 µm in either eye. 12. Any ocular abnormality preventing reliable applanation tonometry of either eye. 13. Significant media opacity in either eye that would exclude adequate posterior segment examination 14. Contraindications to pupil dilation in either eye. 15. Unwillingness to accept known adverse events of latanoprost such as eyelid and/or iris pigmentation, eyelash growth, etc. 16. History of macular edema, including cystoid macular edema, or current or recent (6 months) uveitis. 17. Planned intraocular surgery in either eye during study participation Systemic: 18. Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening. 19. Known hypersensitivity or systemic contraindication to latanoprost or components of study medication. 20. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders), which might interfere with the study. 21. Participation in any investigational study within 30 days prior to baseline. 22. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study. 23. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months | 3 months | The mean change from baseline intraocular pressure at 3 months (0800 hrs) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| POLAT-001 Latanoprost liposome ophthalmic injection
POLAT-001: Subconjunctival injection | 53 |
| Latanoprost Ophthalmic Solution latanoprost ophthalmic solution 0.005%
Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening | 27 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Early exit due to family emergency | 1 | 0 |
Baseline characteristics
| Characteristic | POLAT-001 | Latanoprost Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 9.39 | 63.1 years STANDARD_DEVIATION 11.69 | 63.9 years STANDARD_DEVIATION 10.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 7 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 20 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 22 Participants | 65 Participants |
| Sex: Female, Male Female | 32 Participants | 12 Participants | 44 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 27 |
| other Total, other adverse events | 14 / 53 | 1 / 27 |
| serious Total, serious adverse events | 1 / 53 | 0 / 27 |
Outcome results
Primary
Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months
The mean change from baseline intraocular pressure at 3 months (0800 hrs)
Time frame: 3 months
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| POLAT-001 | Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months | -2.3 mmHg | Standard Deviation 4.6 |
| Latanoprost Ophthalmic Solution | Mean Change in Intraocular Pressure Between Two Measures- Baseline and 3 Months | -6.4 mmHg | Standard Deviation 2.9 |