Phase 2
N=117
A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
Primary Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00595101 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 — -5.12; -5.94; -5.02; -5.25 mmHg (milimeters of mercury)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-03187207 (Drug); Latanoprost 0.005% (Drug); PF-03187207 Vehicle (Drug); Latanoprost Vehicle (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 |
-5.12; -5.94; -5.02; -5.25 | — |
| SECONDARY Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 |
-5.20; -5.87; -4.35; -5.53; -5.63; -6.11 | — |
| SECONDARY Target IOP |
9; 11; 13; 9; 4; 2 | — |
Summary
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
Eligibility Criteria
Inclusion Criteria
- Man or woman at least 20 years of age
- Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.
Exclusion Criteria
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- Contraindications to latanoprost and nitric oxide treatment
- Known latanoprost non-responders
Data sourced from ClinicalTrials.gov (NCT00595101). 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.