Brief Summary
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Brief Title
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Completion Date
Completion Date Type
Actual
Conditions
Open Angle Glaucoma
Ocular Hypertension
Eligibility Criteria
Inclusion Criteria:
* 18 years of age or greater.
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Corrected visual acuity in each eye equivalent to 20/200 or better
* Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria:
Ophthalmic:
* Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
* Intraocular pressure \>36 mmHg
* Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
* Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
* Refractive surgery in study eye(s)
* Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
* Evidence of ocular infection and inflammation
* Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
* Central corneal thickness greater then 600 μm
* Any abnormality preventing reliable applanation tonometry of either eye
Systemic:
* Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
* Clinically significant systemic disease
* Participation in any investigational study within 30 days prior to screening
* Changes in systemic medication
* Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
* 18 years of age or greater.
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Corrected visual acuity in each eye equivalent to 20/200 or better
* Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria:
Ophthalmic:
* Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
* Intraocular pressure \>36 mmHg
* Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
* Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
* Refractive surgery in study eye(s)
* Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
* Evidence of ocular infection and inflammation
* Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
* Central corneal thickness greater then 600 μm
* Any abnormality preventing reliable applanation tonometry of either eye
Systemic:
* Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
* Clinically significant systemic disease
* Participation in any investigational study within 30 days prior to screening
* Changes in systemic medication
* Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Inclusion Criteria
Inclusion Criteria:
* 18 years of age or greater.
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Corrected visual acuity in each eye equivalent to 20/200 or better
* Able and willing to give signed informed consent and follow study instructions.
* 18 years of age or greater.
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Corrected visual acuity in each eye equivalent to 20/200 or better
* Able and willing to give signed informed consent and follow study instructions.
Gender
All
Gender Based
false
Keywords
Open Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
AR13324
PG324
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02057575
Org Class
Industry
Org Full Name
Aerie Pharmaceuticals
Org Study Id
PG324-CS201
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Primary Outcomes
Outcome Description
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
Outcome Measure
Intraocular Pressure (IOP)
Outcome Time Frame
Study treatment was administered for 28 days, and outcome measures collected on Day 29
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
Anurag Shrivastava
Investigator Email
ashrivas@montefiore.org
Investigator Phone