Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Condition: Primary Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PF-04217329 - Lowest Dose; PF-04217329 - Low Dose; PF-04217329 - Middle Dose; PF-04217329 - High Middle Dose; PF-04217329 - High Dose; PF-4217329 - Highest Dose; PF-04217329 - Vehicle; Latanoprost Vehicle; PF-04217329 - Low Dose; Latanoprost Vehicle; PF-04217329 - Middle Dose; Latanoprost Vehicle; PF-04217329 - High Dose; Latanoprost 0.005%; PF-04217329 - Low Dose; Latanoprost 0.005%; PF-04217329 - Middle Dose; Latanoprost 0.005%; PF-04217329 - High Dose; Latanoprost 0.005%; PF-04217329 - Vehicle
Intervention description: 1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.; 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.; Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.; Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.; Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.; Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.; Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.; Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.; Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open-Angle Glaucoma; Ocular Hypertension

Summary:

      To evaluate the safety and efficacy of PF-04217329.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
             or ocular hypertension in 1 or both eyes.

          -  Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2
             measurements.

        Exclusion Criteria:

          -  Closed/barely open anterior chamber angle or a history of acute angle closure in
             either eye.

          -  Anticipate the need to initiate or modify medication (systemic or topical) that is
             known to affect intraocular pressure (IOP) during the study period.