Phase 2
N=31
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
Glaucoma, Open-Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00934089 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) — 22.77; 22.41; 5.00; 3.79 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04217329 (Drug); latanoprost vehicle (Drug); latanoprost (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) |
22.77; 22.41; 5.00; 3.79 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) |
21.40; 20.82; 3.90; 3.09 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) |
21.54; 21.45; 5.15; 4.43 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) |
22.25; 20.80; 6.56; 3.91 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) |
18.56; 17.68; 5.79; 4.50 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) |
19.10; 17.29; 6.42; 3.95 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) |
18.58; 16.66; 6.44; 3.30 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) |
18.25; 17.96; 5.40; 3.88 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) |
17.98; 16.77; 5.71; 4.34 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) |
16.77; 16.66; 4.31; 4.39 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) |
17.98; 17.36; 5.02; 4.32 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) |
23.31; 22.71; 6.19; 4.77 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours) |
1.21; -0.20 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours) |
0.89; -0.95 | — |
| PRIMARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours) |
-0.19; -0.36 | — |
| PRIMARY Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 |
36.20; 43.27 | — |
| PRIMARY Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 |
67.23; 88.65 | — |
| PRIMARY Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 |
47.88; 53.07 | — |
| PRIMARY Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 |
31.68; 30.74 | — |
| PRIMARY Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 |
24.94; 18.96 | — |
| SECONDARY Diastolic Ocular Perfusion Pressure (DOPP) |
57.42; 57.48; 48.28; 48.29; 52.70; 52.84 | — |
| SECONDARY Change From Baseline in Diastolic Ocular Perfusion Pressure (DOPP) at Day 14 (8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM) and Day 15 (12 AM, 2 AM, 4 AM, 6 AM and 8 AM) |
52.81; 53.05; 46.06; 44.57; 47.29; 50.34 | 0.5330 |
| SECONDARY Number of Participants With Ocular and Systemic Adverse Events (AEs) |
29; 25; 30; 28 | — |
| SECONDARY Percentage of Participants With Photophobia and Iritis |
83.33; 24.14; 3.33; 6.90 | <0.001 sig |
| SECONDARY Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 |
562.8; 561.0; 562.5; 560.7; 26.6; 25.0 | — |
| SECONDARY Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 |
2560.7; 2585.3; 2456.5; 2519.1; -41.8; 17.2 | 0.2450 |
Summary
This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
- Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
- Visual acuity correctable to 20/100 or better in each eye.
Exclusion Criteria
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
- Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
- Advanced glaucoma or a history of severe central visual field loss in either eye.
- History of ocular surgery or trauma in either eye within 6 months of the screening visit.
- History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
Data sourced from ClinicalTrials.gov (NCT00934089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.