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A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Xalatan
Xalacom
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 Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.

Exclusion Criteria:

  • History of no-response to timolol
  • History of trabeculectomy
  • History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months

Sites / Locations

  • Nomura Eye Clinic
  • Matsusura Eye Clinic
  • Yasuma Eye Clinic
  • TANABE Eye Clinic
  • Suzuki Eye Clinic
  • Mitsuhashi Eye Clinic
  • Ohtsuka Eye Clinic
  • Sasamoto Eye Clinic
  • Ohyachi Kyouritsu Eye Clinic
  • Kaimeido Eye Clinic
  • Kobe University Hospital
  • Kanazawa university hospital
  • Lumine Hatano Eye Clinic
  • Tanino clinic
  • Aoki eye clinic
  • Kikuna Yuda Eye Clinic
  • Fujita Eye Clinic
  • Chihara Eye Clinic
  • Miyata Eye Hospital
  • Hayashi Eye Clinic
  • Hiraoka Eye Clinic
  • Hanasaki Eye Clinic
  • Nakajima Eye Clinic
  • Yoshimura Eye & Internal Medical Clinic
  • Muramatsu Ganka Clinic
  • The University of Tokyo Hospital
  • Ochanomizu Inoue Eye Clinic
  • Tokyo Metropolitan Police Hospital
  • Keio Hachioji Matsumoto Eye Clinic
  • Manabe Clinic
  • Tokyo Sugita Eye Center
  • Kiyosenomori Hospital
  • Miyazaki Eye Clinic
  • Ohashi Eye Clinic
  • Takase Ganka Tairamachi Clinic
  • Kunitoshi Eye Clinic
  • Shimizu Eye Clinic
  • WAKABA Eye Clinic
  • Seijo Clinic
  • Yotsuya Shirato Ganka
  • Tachihi Bill clinic
  • Ueno Eye Clinic
  • Hayashi Eye Hospital
  • Hayashi Tennjin Eye Clinic
  • Ohshima Hospital of Opthalmology
  • Kato Eye Clinic
  • Gifu University Hospital
  • Hiroshima University Hospital
  • Niigata University Medical and Dental Hospital
  • Nishi Eye Hospital
  • Adachi Eye Clinic
  • Osaka Welfare Pension Hospital
  • Nanba Opthalmology
  • Sugita Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Xalatan

Xalacom

Arm Description

Outcomes

Primary Outcome Measures

Change of Intraocular Pressure (IOP) From Baseline to Week 8
Value at Week 8 minus value at baseline

Secondary Outcome Measures

Change of IOP From Baseline to Week 4
Value at Week 4 minus value at baseline
Number of Subjects With an IOP of <=15 mmHg at Week 8
Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8
Number of Subjects With an IOP of <=16 mmHg at Week 8
Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8
Percent Change of IOP From Baseline to Week 8
Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100
Number of Subjects With an IOP of <=18 mmHg at Week 8
Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8
Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8
Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline
Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8
Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline
Number of Subjects With an IOP of <=17 mmHg at Week 8
Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8

Full Information

First Posted
September 29, 2006
Last Updated
August 16, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00383019
Brief Title
A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Official Title
A 8-WEEK, RANDOMIZED, DOUBLE-MASKED, PARALLEL GROUP, PHASE III STUDY COMPARING THE EFFICACY AND SAFETY OF XALACOM AND XALATAN IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA (POAG) OR OCULAR HYPERTENSION (OH)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 14, 2006 (Actual)
Primary Completion Date
October 1, 2007 (Actual)
Study Completion Date
October 1, 2007 (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

5. Study Description

Brief Summary
This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Xalatan
Arm Type
Experimental
Arm Title
Xalacom
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Xalatan
Intervention Description
latanoprost 0.005%, one rop once daily in evening
Intervention Type
Drug
Intervention Name(s)
Xalacom
Intervention Description
latanoprost 0.005% adn timolol 0.5%, one drop, once daily
Primary Outcome Measure Information:
Title
Change of Intraocular Pressure (IOP) From Baseline to Week 8
Description
Value at Week 8 minus value at baseline
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Change of IOP From Baseline to Week 4
Description
Value at Week 4 minus value at baseline
Time Frame
Baseline to Week 4
Title
Number of Subjects With an IOP of <=15 mmHg at Week 8
Description
Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8
Time Frame
Week 8
Title
Number of Subjects With an IOP of <=16 mmHg at Week 8
Description
Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8
Time Frame
Week 8
Title
Percent Change of IOP From Baseline to Week 8
Description
Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100
Time Frame
Baseline to Week 8
Title
Number of Subjects With an IOP of <=18 mmHg at Week 8
Description
Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8
Time Frame
Week 8
Title
Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8
Description
Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline
Time Frame
Baseline to Week 8
Title
Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8
Description
Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline
Time Frame
Baseline to Week 8
Title
Number of Subjects With an IOP of <=17 mmHg at Week 8
Description
Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more. Exclusion Criteria: History of no-response to timolol History of trabeculectomy History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
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
Nomura Eye Clinic
City
Ichinomiya
State/Province
Aichi
ZIP/Postal Code
491-0837
Country
Japan
Facility Name
Matsusura Eye Clinic
City
Ichinomiya
State/Province
Aichi
ZIP/Postal Code
491-0858
Country
Japan
Facility Name
Yasuma Eye Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0011
Country
Japan
Facility Name
TANABE Eye Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-0054
Country
Japan
Facility Name
Suzuki Eye Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-0806
Country
Japan
Facility Name
Mitsuhashi Eye Clinic
City
Narashino
State/Province
Chiba
ZIP/Postal Code
275-0016
Country
Japan
Facility Name
Ohtsuka Eye Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
001-0016
Country
Japan
Facility Name
Sasamoto Eye Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
001-0039
Country
Japan
Facility Name
Ohyachi Kyouritsu Eye Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Kaimeido Eye Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
062-0020
Country
Japan
Facility Name
Kobe University Hospital
City
Koube
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kanazawa university hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-0934
Country
Japan
Facility Name
Lumine Hatano Eye Clinic
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-0052
Country
Japan
Facility Name
Tanino clinic
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
248-0035
Country
Japan
Facility Name
Aoki eye clinic
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-0806
Country
Japan
Facility Name
Kikuna Yuda Eye Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0011
Country
Japan
Facility Name
Fujita Eye Clinic
City
Sapporo
State/Province
Kokkaido
ZIP/Postal Code
003-0062
Country
Japan
Facility Name
Chihara Eye Clinic
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0043
Country
Japan
Facility Name
Miyata Eye Hospital
City
Miyakonojo
State/Province
Miyazaki
ZIP/Postal Code
885-0051
Country
Japan
Facility Name
Hayashi Eye Clinic
City
Kumagaya
State/Province
Saitama
ZIP/Postal Code
360-0843
Country
Japan
Facility Name
Hiraoka Eye Clinic
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1116
Country
Japan
Facility Name
Hanasaki Eye Clinic
City
Fuji
State/Province
Shizuoka
ZIP/Postal Code
416-0952
Country
Japan
Facility Name
Nakajima Eye Clinic
City
Fuji
State/Province
Shizuoka
ZIP/Postal Code
419-0204
Country
Japan
Facility Name
Yoshimura Eye & Internal Medical Clinic
City
Mishima
State/Province
Shizuoka
ZIP/Postal Code
411-0824
Country
Japan
Facility Name
Muramatsu Ganka Clinic
City
Susono
State/Province
Shizuoka
ZIP/Postal Code
410-1102
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Ochanomizu Inoue Eye Clinic
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0062
Country
Japan
Facility Name
Tokyo Metropolitan Police Hospital
City
Chiyoda
State/Province
Tokyo
ZIP/Postal Code
102-8161
Country
Japan
Facility Name
Keio Hachioji Matsumoto Eye Clinic
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
Facility Name
Manabe Clinic
City
Hamura
State/Province
Tokyo
ZIP/Postal Code
205-0001
Country
Japan
Facility Name
Tokyo Sugita Eye Center
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
125-0041
Country
Japan
Facility Name
Kiyosenomori Hospital
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-0021
Country
Japan
Facility Name
Miyazaki Eye Clinic
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0076
Country
Japan
Facility Name
Ohashi Eye Clinic
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-0043
Country
Japan
Facility Name
Takase Ganka Tairamachi Clinic
City
Meguro
State/Province
Tokyo
ZIP/Postal Code
152-0032
Country
Japan
Facility Name
Kunitoshi Eye Clinic
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
180-0004
Country
Japan
Facility Name
Shimizu Eye Clinic
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
180-0022
Country
Japan
Facility Name
WAKABA Eye Clinic
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
144-052
Country
Japan
Facility Name
Seijo Clinic
City
Setagaya
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
Facility Name
Yotsuya Shirato Ganka
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
160-0004
Country
Japan
Facility Name
Tachihi Bill clinic
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0003
Country
Japan
Facility Name
Ueno Eye Clinic
City
Taito-ku
State/Province
Tokyo
ZIP/Postal Code
110-015
Country
Japan
Facility Name
Hayashi Eye Hospital
City
Fujuoka
ZIP/Postal Code
812-0011
Country
Japan
Facility Name
Hayashi Tennjin Eye Clinic
City
Fukuoka
ZIP/Postal Code
810-0002
Country
Japan
Facility Name
Ohshima Hospital of Opthalmology
City
Fukuoka
ZIP/Postal Code
812-0036
Country
Japan
Facility Name
Kato Eye Clinic
City
Fukuoka
ZIP/Postal Code
814-0133
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
ZIP/Postal Code
951-8122
Country
Japan
Facility Name
Nishi Eye Hospital
City
Osaka
ZIP/Postal Code
537-0025
Country
Japan
Facility Name
Adachi Eye Clinic
City
Osaka
ZIP/Postal Code
557-0044
Country
Japan
Facility Name
Osaka Welfare Pension Hospital
City
Osaka
Country
Japan
Facility Name
Nanba Opthalmology
City
Shizuoka
ZIP/Postal Code
420-0833
Country
Japan
Facility Name
Sugita Eye Hospital
City
Sugita
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6641050&StudyName=A%20Study%20Comparing%20Xalacom%20And%20Xalatan%20In%20Patients%20With%20Primary%20Open%20Angle%20Glaucoma%20%28POAG%29%20Or%20Ocular%20Hypertension%20%28OH%29.%0A
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).

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