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Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441883
First Posted: March 1, 2007
Last Update Posted: December 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NicOx Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
February 27, 2007
March 1, 2007
December 13, 2013
March 2007
February 2008   (Final data collection date for primary outcome measure)
Change in diurnal intraocular pressure (IOP) at day 28 [ Time Frame: 28 days ]
Change in diurnal intraocular pressure (IOP) at day 28
Complete list of historical versions of study NCT00441883 on ClinicalTrials.gov Archive Site
  • Change in resting pulse and blood pressure, and clinical laboratories throughout the study period [ Time Frame: 28 days ]
  • Determine the impact of dose timing [ Time Frame: 28 days ]
  • Change from baseline IOP at the Day 7, 14, 21, and 28 visits [ Time Frame: 28 days ]
  • Proportion of patients at target IOP across all study visits [ Time Frame: 28 days ]
  • Change in safety assessments, ocular and systemic adverse events throughout study period [ Time Frame: 28 days ]
  • Change in refraction, visual acuity, visual fields throughout study period [ Time Frame: 28 days ]
  • Change in pupil diameter, biomicroscopic examination throughout study period [ Time Frame: 28 days ]
  • Change in ophthalmoscopy, gonioscopy, pachymetry throughout study period [ Time Frame: 28 days ]
  • Change from baseline IOP at the Day 7, 14, 21, and 28 visits
  • Proportion of patients at target IOP across all study visits
  • Change in safety assessments (ocular and systemic adverse events,
  • refraction, visual acuity, visual fields, pupil diameter,
  • biomicroscopic examination, ophthalmoscopy, gonioscopy, pachymetry,
  • resting pulse and blood pressure, and clinical laboratories) throughout
  • the study period
Not Provided
Not Provided
 
Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma
A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost
This study will evaluate the safety and efficacy of PF 03187207.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
  • Pigmentary Glaucoma
  • Pseudoexfoliative Glaucoma
  • Drug: PF-03187207 and Latanoprost Vehicle
  • Drug: Latanoprost 0.005% and PF-03187207 Vehicle
  • Experimental: PF-03187207 and Latanoprost Vehicle
    One drop of each, once daily in study eye for 28 days
    Intervention: Drug: PF-03187207 and Latanoprost Vehicle
  • Active Comparator: Latanoprost 0.005% and PF-03187207 Vehicle
    One drop of each, once daily in study eye for 28 days
    Intervention: Drug: Latanoprost 0.005% and PF-03187207 Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
July 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

-Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes

Exclusion Criteria:

-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00441883
A9441001
Yes
Not Provided
Not Provided
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
NicOx Inc.
Study Director: Kenneth Harper Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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