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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:
Collaborator:
NicOx Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00441883
First received: February 27, 2007
Last updated: November 20, 2013
Last verified: November 2013

February 27, 2007
November 20, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • Determine the impact of dose timing [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change from baseline IOP at the Day 7, 14, 21, and 28 visits [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Proportion of patients at target IOP across all study visits [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in safety assessments, ocular and systemic adverse events throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in refraction, visual acuity, visual fields throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in pupil diameter, biomicroscopic examination throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in ophthalmoscopy, gonioscopy, pachymetry throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00441883
A9441001
Yes
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