A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
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)
1 other identifier
interventional
300
1 country
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 2, 2006
CompletedStudy Start
First participant enrolled
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
May 27, 2009
CompletedSeptember 8, 2021
August 1, 2021
11 months
September 29, 2006
October 1, 2008
August 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Intraocular Pressure (IOP) From Baseline to Week 8
Value at Week 8 minus value at baseline
Baseline to Week 8
Secondary Outcomes (8)
Change of IOP From Baseline to Week 4
Baseline to Week 4
Number of Subjects With an IOP of <=15 mmHg at Week 8
Week 8
Number of Subjects With an IOP of <=16 mmHg at Week 8
Week 8
Percent Change of IOP From Baseline to Week 8
Baseline to Week 8
Number of Subjects With an IOP of <=18 mmHg at Week 8
Week 8
- +3 more secondary outcomes
Study Arms (2)
Xalatan
EXPERIMENTALXalacom
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.
You may not qualify if:
- History of no-response to timolol
- History of trabeculectomy
- History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Nomura Eye Clinic
Ichinomiya, Aichi-ken, 491-0837, Japan
Matsusura Eye Clinic
Ichinomiya, Aichi-ken, 491-0858, Japan
Yasuma Eye Clinic
Nagoya, Aichi-ken, 460-0011, Japan
TANABE Eye Clinic
Nagoya, Aichi-ken, 466-0054, Japan
Suzuki Eye Clinic
Nagoya, Aichi-ken, 467-0806, Japan
Mitsuhashi Eye Clinic
Narashino, Chiba, 275-0016, Japan
Ohtsuka Eye Clinic
Sapporo, Hokkaido, 001-0016, Japan
Sasamoto Eye Clinic
Sapporo, Hokkaido, 001-0039, Japan
Ohyachi Kyouritsu Eye Clinic
Sapporo, Hokkaido, 004-0041, Japan
Kaimeido Eye Clinic
Sapporo, Hokkaido, 062-0020, Japan
Kobe University Hospital
Koube, Hyōgo, 650-0017, Japan
Kanazawa university hospital
Kanazawa, Ishikawa-ken, 920-0934, Japan
Lumine Hatano Eye Clinic
Fujisawa, Kanagawa, 251-0052, Japan
Tanino clinic
Kamakura, Kanagawa, 248-0035, Japan
Aoki eye clinic
Sagamihara, Kanagawa, 228-0806, Japan
Kikuna Yuda Eye Clinic
Yokohama, Kanagawa, 222-0011, Japan
Fujita Eye Clinic
Sapporo, Kokkaido, 003-0062, Japan
Chihara Eye Clinic
Uji, Kyoto, 611-0043, Japan
Miyata Eye Hospital
Miyakonojō, Miyazaki, 885-0051, Japan
Hayashi Eye Clinic
Kumagaya, Saitama, 360-0843, Japan
Hiraoka Eye Clinic
Tokorozawa, Saitama, 359-1116, Japan
Hanasaki Eye Clinic
Fuji, Shizuoka, 416-0952, Japan
Nakajima Eye Clinic
Fuji, Shizuoka, 419-0204, Japan
Yoshimura Eye & Internal Medical Clinic
Mishima, Shizuoka, 411-0824, Japan
Muramatsu Ganka Clinic
Susono, Shizuoka, 410-1102, Japan
The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
Tokyo Metropolitan Police Hospital
Chiyoda City, Tokyo, 102-8161, Japan
Ochanomizu Inoue Eye Clinic
Chiyoda-ku, Tokyo, 101-0062, Japan
Keio Hachioji Matsumoto Eye Clinic
Hachiōji, Tokyo, 192-0046, Japan
Manabe Clinic
Hamura, Tokyo, 205-0001, Japan
Tokyo Sugita Eye Center
Katsushika-ku, Tokyo, 125-0041, Japan
Kiyosenomori Hospital
Kiyose, Tokyo, 204-0021, Japan
Miyazaki Eye Clinic
Koto-ku, Tokyo, 136-0076, Japan
Takase Ganka Tairamachi Clinic
Meguro City, Tokyo, 152-0032, Japan
Ohashi Eye Clinic
Meguro-ku, Tokyo, 153-0043, Japan
Kunitoshi Eye Clinic
Musashino, Tokyo, 180-0004, Japan
Shimizu Eye Clinic
Musashino, Tokyo, 180-0022, Japan
WAKABA Eye Clinic
Ōta-ku, Tokyo, 144-052, Japan
Seijo Clinic
Setagaya City, Tokyo, 157-0066, Japan
Yotsuya Shirato Ganka
Shinjuku, Tokyo, 160-0004, Japan
Tachihi Bill clinic
Tachikawa, Tokyo, 190-0003, Japan
Ueno Eye Clinic
Taito-ku, Tokyo, 110-015, Japan
Hayashi Eye Hospital
Fujuoka, 812-0011, Japan
Hayashi Tennjin Eye Clinic
Fukuoka, 810-0002, Japan
Ohshima Hospital of Opthalmology
Fukuoka, 812-0036, Japan
Kato Eye Clinic
Fukuoka, 814-0133, Japan
Gifu University Hospital
Gifu, 501-1194, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Niigata University Medical and Dental Hospital
Niigata, 951-8122, Japan
Nishi Eye Hospital
Osaka, 537-0025, Japan
Adachi Eye Clinic
Osaka, 557-0044, Japan
Osaka Welfare Pension Hospital
Osaka, Japan
Nanba Opthalmology
Shizuoka, 420-0833, Japan
Sugita Eye Hospital
Sugita, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 2, 2006
Study Start
November 14, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
September 8, 2021
Results First Posted
May 27, 2009
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
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.