A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00595101
First received: January 4, 2008
Last updated: November 20, 2013
Last verified: November 2013
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Purpose
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
Drug Information available for:
Latanoprost
U.S. FDA Resources
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Reduction in intraocular pressure (IOP) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]Mean reduction in diurnal IOP from baseline on Day 28
Secondary Outcome Measures:
- IOP level across scheduled time points [ Time Frame: Day 14 and Day 28 ] [ Designated as safety issue: No ]
- Target IOP [ Time Frame: Over all visits through Day 28 ] [ Designated as safety issue: No ]Proportion of subjects with ≤ target IOPs across all measured time points.
| Enrollment: | 128 |
| Study Start Date: | December 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595101
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595101
Locations
| 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 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Ken Harper | Bausch & Lomb Incorporated |
More Information
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00595101 History of Changes |
| Other Study ID Numbers: | A9441003 |
| Study First Received: | January 4, 2008 |
| Last Updated: | November 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Latanoprost Antihypertensive Agents |
ClinicalTrials.gov processed this record on September 30, 2016