Brief Summary
In the double-masked, randomized, multi-center, active-controlled parallel study, patients will be randomized to receive either a fixed dose combination of AR-12286 and travoprost, AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment arm.
Brief Title
A Study Assessing PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components for 28 Days
Completion Date
Completion Date Type
Actual
Conditions
Open Angle Glaucoma
Ocular Hypertension
Eligibility Criteria
Subject inclusion criteria
1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \>21 mmHg at 10:00 and 16:00 hrs.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.
Subject exclusion criteria
Excluded from the study will be individuals with the following characteristics:
Ophthalmic (in either eye):
1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
2. Intraocular pressure \> 35 mm Hg, or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, zinc, etc.), travoprost, or to topical anesthetics.
4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
5. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
7. Evidence of ocular infection, inflammation, clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis at screening.
8. Ocular medication of any kind within 30 days of screening, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after screening) or c) lubricating drops for dry eye (which may be used throughout the study).
9. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (e.g., cup-disc ratio \> 0.8).
10. Central corneal thickness greater than 600 µm.
11. Any abnormality preventing reliable applanation tonometry of either eye.
Systemic:
12. Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
14. Participation in any investigational study within 30 days prior to screening.
15. Changes of systemic medication within 30 days prior to screening, or anticipated during the study, that could have a substantial effect on IOP.
16. 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 screening examination and must not intend to become pregnant during the study.
1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \>21 mmHg at 10:00 and 16:00 hrs.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.
Subject exclusion criteria
Excluded from the study will be individuals with the following characteristics:
Ophthalmic (in either eye):
1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
2. Intraocular pressure \> 35 mm Hg, or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, zinc, etc.), travoprost, or to topical anesthetics.
4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
5. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
7. Evidence of ocular infection, inflammation, clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis at screening.
8. Ocular medication of any kind within 30 days of screening, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after screening) or c) lubricating drops for dry eye (which may be used throughout the study).
9. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (e.g., cup-disc ratio \> 0.8).
10. Central corneal thickness greater than 600 µm.
11. Any abnormality preventing reliable applanation tonometry of either eye.
Systemic:
12. Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
14. Participation in any investigational study within 30 days prior to screening.
15. Changes of systemic medication within 30 days prior to screening, or anticipated during the study, that could have a substantial effect on IOP.
16. 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 screening examination and must not intend to become pregnant during the study.
Inclusion Criteria
inclusion criteria
1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \>21 mmHg at 10:00 and 16:00 hrs.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.
Subject
1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \>21 mmHg at 10:00 and 16:00 hrs.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.
Subject
Gender
All
Gender Based
false
Keywords
Glaucoma
Ocular hypertension
AR-12286
Travoprost
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01789736
Org Class
Industry
Org Full Name
Aerie Pharmaceuticals
Org Study Id
PG286-CS202
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Study Assessing the Safety and Ocular Hypotensive Efficacy of PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components
Primary Outcomes
Outcome Description
The primary efficacy endpoint will be the mean diurnal IOP across subjects within treatment group and time point at Day 28.
Outcome Measure
Mean diurnal IOP
Outcome Time Frame
28 Days
Secondary Outcomes
Outcome Description
Secondary efficacy endpoints will include: mean IOP across subjects within treatment group at each post-treatment timepoint, mean change from diurnally adjusted baseline IOP at each timepoint, mean percent change from diurnally adjusted baseline IOP at each timepoint, mean diurnal IOP at other visits, and mean change from the baseline mean diurnal IOP at each visits.
Outcome Time Frame
7-28 days
Outcome Measure
IOP
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jeffrey Schultz
Investigator Email
jschultz@montefiore.org
Investigator Phone