Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2014 |
End Date: | June 2014 |
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its
individual components in patients with open angle glaucoma or ocular hypertension.
individual components in patients with open angle glaucoma or ocular hypertension.
Inclusion Criteria:
- 18 years of age or greater.
- Diagnosis of open angle glaucoma or ocular hypertension
- Corrected visual acuity in each eye equivalent to 20/200
- Able and willing to give signed informed consent and follow study instructions.
- Additional protocol-specific criteria may apply
Exclusion Criteria:
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle
closure, or narrow angles.
- Known hypersensitivity to any component of the formulation (benzalkonium chloride,
etc.), 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.
- 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
- Clinically significant abnormalities (as determined by the investigator) in
laboratory tests at screening.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia
gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere
with the study.
- 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.
- Additional protocol-specific criteria may apply
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