Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00441883
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : August 27, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborator:
NicOx Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
This study will evaluate the safety and efficacy of PF 03187207.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma Drug: PF-03187207 and Latanoprost Vehicle Drug: Latanoprost 0.005% and PF-03187207 Vehicle Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Study Start Date : March 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: PF-03187207 and Latanoprost Vehicle
One drop of each, once daily in study eye for 28 days
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
Drug: Latanoprost 0.005% and PF-03187207 Vehicle



Primary Outcome Measures :
  1. Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 [ Time Frame: Baseline, 28 days ]
    Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits [ Time Frame: Baseline, Day 7, Day 14, and Day 21 ]
    Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. gBoth eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.

  2. Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 [ Time Frame: 28 days ]
    Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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): NCT00441883


Locations
Layout table for location information
United States, California
Pfizer Investigational Site
Artesia, California, United States, 90701
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Petaluma, California, United States, 94954
Pfizer Investigational Site
Poway, California, United States, 92064
United States, Connecticut
Pfizer Investigational Site
Danbury, Connecticut, United States, 06810-4004
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32204
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47710
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
High Point, North Carolina, United States, 27262
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Pfizer Investigational Site
Cranberry Township, Pennsylvania, United States, 16066
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15238
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Sponsors and Collaborators
Bausch & Lomb Incorporated
NicOx Inc.
Investigators
Layout table for investigator information
Study Director: Kenneth Harper Bausch & Lomb Incorporated
Additional Information:
Layout table for additonal information
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00441883    
Other Study ID Numbers: A9441001
First Posted: March 1, 2007    Key Record Dates
Results First Posted: August 27, 2020
Last Update Posted: September 14, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions