Phase 2
N=67
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Primary Open-Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00572455 ↗Enrolled (actual)
67
Serious AEs
1.0%
Results posted
Apr 2021
Primary outcome: Primary: Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I — 25.97; 26.25; 25.90; 26.44 mmHg — p=0.028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04217329 - Lowest Dose (Drug); PF-04217329 - Low Dose (Drug); PF-04217329 - Middle Dose (Drug); PF-04217329 - High Middle Dose (Drug); PF-04217329 - High Dose (Drug); PF-4217329 - Highest Dose (Drug); PF-04217329 - Vehicle (Drug); Latanoprost Vehicle (Drug); Latanoprost 0.005% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I |
25.97; 26.25; 25.90; 26.44; 28.10; 26.26 | 0.028 sig |
| PRIMARY Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II |
25.75; 26.47; 26.69; 26.98; 26.36; 27.34 | 0.171 |
| PRIMARY Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I |
1; 2; 0; 5; 4; 9 | — |
| PRIMARY Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II |
17; 20; 27; 24; 26; 26 | — |
| SECONDARY Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I |
22.89; 22.28; 20.00; 21.70; 22.06; 21.22 | — |
| SECONDARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I |
27.78; 27.72; 27.72; 28.45; 29.81; 28.44 | 0.011 sig |
| SECONDARY Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II |
19.12; 21.91; 20.61; 19.39; 18.76; 19.69 | — |
| SECONDARY Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II |
27.34; 28.21; 28.27; 29.10; 28.63; 29.19 | 0.377 |
| SECONDARY Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I |
0.0; 11.1; 11.1; 0.0; 11.1; 22.2 | — |
| SECONDARY Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II |
22.9; 2.8; 13.9; 8.3; 38.9; 16.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00572455). 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.