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A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

Primary Purpose

Ocular Hypertension, Glaucoma, Open-angle Glaucoma

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
i. Fixed combination of latanoprost 0.005% and timolol 0.5%
timolol 0.5% ophthalmic solution
latanoprost 0.005% ophthalmic solution
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 open-angle glaucoma ocular hypertension glaucoma

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 (two 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.
  • Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
  • Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
  • Pregnancy
  • Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
  • 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
  • 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
  • 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%

timolol 0.5% ophthalmic solution

latanoprost 0.005% ophthalmic solution

Arm Description

one drop in the morning and evening

placebo in the morning and latanoprost .005% in the evening

Outcomes

Primary Outcome Measures

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 treatments at Week 26
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26
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
March 2, 2009
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
NCT00856622
Brief Title
A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 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
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma, Open-angle Glaucoma
Keywords
open-angle glaucoma ocular hypertension glaucoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fixed combination of latanoprost 0.005% and timolol 0.5%
Arm Type
Experimental
Arm Title
timolol 0.5% ophthalmic solution
Arm Type
Active Comparator
Arm Description
one drop in the morning and evening
Arm Title
latanoprost 0.005% ophthalmic solution
Arm Type
Active Comparator
Arm Description
placebo in the morning and latanoprost .005% in the evening
Intervention Type
Drug
Intervention Name(s)
i. Fixed combination of latanoprost 0.005% and timolol 0.5%
Other Intervention Name(s)
xalacom, xalcom
Intervention Description
one drop in the morning and placebo in the evening
Intervention Type
Drug
Intervention Name(s)
timolol 0.5% ophthalmic solution
Other Intervention Name(s)
timoptic
Intervention Description
one drop in the morning and evening
Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% ophthalmic solution
Other Intervention Name(s)
xalatan
Intervention Description
placebo in the morning and latanoprost .005% in the evening
Primary Outcome Measure Information:
Title
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 treatments at Week 26
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 compare 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 compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26
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 (two 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. Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed. Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed). Pregnancy Women of childbearing potential who has not used adequate contraceptive methods during the last three months. 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
Aachen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Aalen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ahaus
ZIP/Postal Code
48683
Country
Germany
Facility Name
Pfizer Investigational Site
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Pfizer Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bad Abbach
ZIP/Postal Code
93077
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13088
Country
Germany
Facility Name
Pfizer Investigational Site
City
Coesfeld
ZIP/Postal Code
48653
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dillingen
ZIP/Postal Code
89407
Country
Germany
Facility Name
Pfizer Investigational Site
City
Eitorf
ZIP/Postal Code
53783
Country
Germany
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Pfizer Investigational Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freising
ZIP/Postal Code
85354
Country
Germany
Facility Name
Pfizer Investigational Site
City
Fulda
Country
Germany
Facility Name
Pfizer Investigational Site
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Facility Name
Pfizer Investigational Site
City
Gummersbach
ZIP/Postal Code
51643
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hannover
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hirschaid
ZIP/Postal Code
96114
Country
Germany
Facility Name
Pfizer Investigational Site
City
Iserlohn
ZIP/Postal Code
58638
Country
Germany
Facility Name
Pfizer Investigational Site
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leonberg
ZIP/Postal Code
71229
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55124
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mülheim
ZIP/Postal Code
45481
Country
Germany
Facility Name
Pfizer Investigational Site
City
Münster
ZIP/Postal Code
48165
Country
Germany
Facility Name
Pfizer Investigational Site
City
Offenbach
ZIP/Postal Code
63065
Country
Germany
Facility Name
Pfizer Investigational Site
City
Osnabrueck
ZIP/Postal Code
49076
Country
Germany
Facility Name
Pfizer Investigational Site
City
Parsberg
ZIP/Postal Code
92331
Country
Germany
Facility Name
Pfizer Investigational Site
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Pfizer Investigational Site
City
Sulzbach
ZIP/Postal Code
66280
Country
Germany
Facility Name
Pfizer Investigational Site
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
Pfizer Investigational Site
City
Weiden
ZIP/Postal Code
92637
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=96TIPG004
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients

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