A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
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ClinicalTrials.gov Identifier: NCT00595101 |
Recruitment Status
:
Completed
First Posted
: January 16, 2008
Last Update Posted
: December 13, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Open Angle Glaucoma Ocular Hypertension | Drug: PF-03187207 Drug: Latanoprost 0.005% Drug: PF-03187207 Vehicle Drug: Latanoprost Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension. |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: PF-03187207 High Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
|
Drug: PF-03187207 Drug: Latanoprost Vehicle |
Experimental: Latanoprost 0.005% and PF-03187207 Vehicle
A single drop of each, once daily in study eye for 28 days
|
Drug: Latanoprost 0.005%
Drug: PF-03187207 Vehicle
One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
|
Experimental: PF-03187207 Medium Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
|
Drug: PF-03187207 Drug: Latanoprost Vehicle |
Experimental: PF-03187207 Low Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
|
Drug: PF-03187207 Drug: Latanoprost Vehicle |
- Reduction in intraocular pressure (IOP) [ Time Frame: Day 28 ]Mean reduction in diurnal IOP from baseline on Day 28
- IOP level across scheduled time points [ Time Frame: Day 14 and Day 28 ]
- Target IOP [ Time Frame: Over all visits through Day 28 ]Proportion of subjects with ≤ target IOPs across all measured time points.

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595101
Japan | |
Pfizer Investigational Site | |
Inbagun Suimachi, Chiba, Japan | |
Pfizer Investigational Site | |
Narashino, Chiba, Japan | |
Pfizer Investigational Site | |
Kawasaki, Kanagawa, Japan | |
Pfizer Investigational Site | |
Kasukabe, Saitama, Japan | |
Pfizer Investigational Site | |
Fuji, Shizuoka, Japan | |
Pfizer Investigational Site | |
Mishima, Shizuoka, Japan | |
Pfizer Investigational Site | |
Susono, Shizuoka, Japan | |
Pfizer Investigational Site | |
Hachioji, Tokyo, Japan | |
Pfizer Investigational Site | |
Hamura, Tokyo, Japan | |
Pfizer Investigational Site | |
Minato, Tokyo, Japan | |
Pfizer Investigational Site | |
Musashino, Tokyo, Japan | |
Pfizer Investigational Site | |
Setagaya, Tokyo, Japan | |
Pfizer Investigational Site | |
Shizuoka, Japan |
Study Director: | Ken Harper | Bausch & Lomb Incorporated |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00595101 History of Changes |
Other Study ID Numbers: |
A9441003 |
First Posted: | January 16, 2008 Key Record Dates |
Last Update Posted: | December 13, 2013 |
Last Verified: | November 2013 |
Additional relevant MeSH terms:
Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Latanoprost Antihypertensive Agents |