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A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

Primary Purpose

Ocular Hypertension, Glaucoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
latanoprost 0.005%
fixed combination latanoprost-timolol
timolol 0.5%
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension focused on measuring glaucoma, ocular hypertension, Fixed combination latanoprost-timolol, latanoprost, timolol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
  • Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

  • History of acute angle closure or closed/barely open anterior chamber angle.
  • Current use of contact lenses.
  • Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
  • Ocular inflammation/infection occurring within three months prior to pre-study visit.
  • Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
  • Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
  • Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
  • Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
  • Inability to adhere to treatment/visit plan.
  • Have participated in any other clinical study within one month prior to pre-study visit.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Fixed combination of latanoprost 0.005% and timolol 0.5%

latanoprost 0.005%

Timolol - 0.5%

Arm Description

Outcomes

Primary Outcome Measures

The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.

Secondary Outcome Measures

To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
To describe the IOP development from baseline to Week 26 for all treatment groups
To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
To follow the safety variables throughout the study periods.

Full Information

First Posted
November 3, 2008
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00800267
Brief Title
A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Official Title
A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
June 1999 (Actual)
Study Completion Date
June 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma
Keywords
glaucoma, ocular hypertension, Fixed combination latanoprost-timolol, latanoprost, timolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixed combination of latanoprost 0.005% and timolol 0.5%
Arm Type
Experimental
Arm Title
latanoprost 0.005%
Arm Type
Active Comparator
Arm Title
Timolol - 0.5%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005%
Intervention Description
placebo in the morning and latanoprost .005% in the evening
Intervention Type
Drug
Intervention Name(s)
fixed combination latanoprost-timolol
Intervention Description
one drop in the morning and placebo in the evening
Intervention Type
Drug
Intervention Name(s)
timolol 0.5%
Intervention Description
one drop in the morning and evening
Primary Outcome Measure Information:
Title
The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
Time Frame
6 months
Title
Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol
Time Frame
6 months
Title
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
Time Frame
6 months
Title
To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
Time Frame
6 months
Title
To describe the IOP development from baseline to Week 26 for all treatment groups
Time Frame
6 months
Title
To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination
Time Frame
6 months
Title
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
Time Frame
6 months
Title
To follow the safety variables throughout the study periods.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension. Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour). Exclusion Criteria: History of acute angle closure or closed/barely open anterior chamber angle. Current use of contact lenses. Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit. Ocular inflammation/infection occurring within three months prior to pre-study visit. Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions. Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement. Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block. Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. Inability to adhere to treatment/visit plan. Have participated in any other clinical study within one month prior to pre-study visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92807
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Pfizer Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pfizer Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304-3573
Country
United States
Facility Name
Pfizer Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Pfizer Investigational Site
City
Largo
State/Province
Florida
ZIP/Postal Code
34640
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
Pfizer Investigational Site
City
East Point
State/Province
Georgia
ZIP/Postal Code
30223
Country
United States
Facility Name
Pfizer Investigational Site
City
Griffin
State/Province
Georgia
ZIP/Postal Code
30223
Country
United States
Facility Name
Pfizer Investigational Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Wheaton
State/Province
Illinois
ZIP/Postal Code
60187
Country
United States
Facility Name
Pfizer Investigational Site
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Pfizer Investigational Site
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Pfizer Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Pfizer Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Pfizer Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Pfizer Investigational Site
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Pfizer Investigational Site
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55421
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Pfizer Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Pfizer Investigational Site
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Pfizer Investigational Site
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Pfizer Investigational Site
City
South Plainfield
State/Province
New Jersey
ZIP/Postal Code
07080
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28260
Country
United States
Facility Name
Pfizer Investigational Site
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Pfizer Investigational Site
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Pfizer Investigational Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464-3245
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-4941
Country
United States
Facility Name
Pfizer Investigational Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1141
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=96TIPG005&StudyName=A%20study%20of%20glaucoma%20or%20ocular%20hypertension%20in%20patients%20within%20the%20United%20States.
Description
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Learn more about this trial

A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

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