Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PG324 Ophthalmic Solution 0.01%; PG324 Ophthalmic Solution 0.02%; Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Latanoprost Ophthalmic Solution 0.005%
Intervention description: 1 drop in the evening (PM), once daily (QD), both eyes (OU); 1 drop in the evening (PM), once daily (QD), both eyes (OU); 1 drop in the evening (PM), once daily (QD), both eyes (OU); 1 drop in the evening (PM), once daily (QD), both eyes (OU)
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open Angle Glaucoma; Ocular Hypertension; Intraocular Pressure; AR13324; PG324

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.
    

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.