Clinical trial NCT00383019: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of Intraocular Pressure (IOP) From Baseline to Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change of IOP From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Number of Subjects With an IOP of <=15 mmHg at Week 8
timeFrame: Week 8
measure: Number of Subjects With an IOP of <=16 mmHg at Week 8
timeFrame: Week 8
measure: Percent Change of IOP From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Number of Subjects With an IOP of <=18 mmHg at Week 8
timeFrame: Week 8
measure: Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Number of Subjects With an IOP of <=17 mmHg at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Ichinomiya
country: Japan
facility: Nomura Eye Clinic
state: Aichi
city: Ichinomiya
country: Japan
facility: Matsusura Eye Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Yasuma Eye Clinic
state: Aichi
city: Nagoya
country: Japan
facility: TANABE Eye Clinic
state: Aichi
city: Nagoya
country: Japan
facility: Suzuki Eye Clinic
state: Aichi
city: Narashino
country: Japan
facility: Mitsuhashi Eye Clinic
state: Chiba
city: Sapporo
country: Japan
facility: Ohtsuka Eye Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sasamoto Eye Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Ohyachi Kyouritsu Eye Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Kaimeido Eye Clinic
state: Hokkaido
city: Koube
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa university hospital
state: Ishikawa
city: Fujisawa
country: Japan
facility: Lumine Hatano Eye Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Tanino clinic
state: Kanagawa
city: Sagamihara
country: Japan
facility: Aoki eye clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Kikuna Yuda Eye Clinic
state: Kanagawa
city: Sapporo
country: Japan
facility: Fujita Eye Clinic
state: Kokkaido
city: Uji
country: Japan
facility: Chihara Eye Clinic
state: Kyoto
city: Miyakonojo
country: Japan
facility: Miyata Eye Hospital
state: Miyazaki
city: Kumagaya
country: Japan
facility: Hayashi Eye Clinic
state: Saitama
city: Tokorozawa
country: Japan
facility: Hiraoka Eye Clinic
state: Saitama
city: Fuji
country: Japan
facility: Hanasaki Eye Clinic
state: Shizuoka
city: Fuji
country: Japan
facility: Nakajima Eye Clinic
state: Shizuoka
city: Mishima
country: Japan
facility: Yoshimura Eye & Internal Medical Clinic
state: Shizuoka
city: Susono
country: Japan
facility: Muramatsu Ganka Clinic
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Ochanomizu Inoue Eye Clinic
state: Tokyo
city: Chiyoda
country: Japan
facility: Tokyo Metropolitan Police Hospital
state: Tokyo
city: Hachioji
country: Japan
facility: Keio Hachioji Matsumoto Eye Clinic
state: Tokyo
city: Hamura
country: Japan
facility: Manabe Clinic
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Tokyo Sugita Eye Center
state: Tokyo
city: Kiyose
country: Japan
facility: Kiyosenomori Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Miyazaki Eye Clinic
state: Tokyo
city: Meguro-ku
country: Japan
facility: Ohashi Eye Clinic
state: Tokyo
city: Meguro
country: Japan
facility: Takase Ganka Tairamachi Clinic
state: Tokyo
city: Musashino
country: Japan
facility: Kunitoshi Eye Clinic
state: Tokyo
city: Musashino
country: Japan
facility: Shimizu Eye Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: WAKABA Eye Clinic
state: Tokyo
city: Setagaya
country: Japan
facility: Seijo Clinic
state: Tokyo
city: Shinjuku
country: Japan
facility: Yotsuya Shirato Ganka
state: Tokyo
city: Tachikawa
country: Japan
facility: Tachihi Bill clinic
state: Tokyo
city: Taito-ku
country: Japan
facility: Ueno Eye Clinic
state: Tokyo
city: Fujuoka
country: Japan
facility: Hayashi Eye Hospital
city: Fukuoka
country: Japan
facility: Hayashi Tennjin Eye Clinic
city: Fukuoka
country: Japan
facility: Ohshima Hospital of Opthalmology
city: Fukuoka
country: Japan
facility: Kato Eye Clinic
city: Gifu
country: Japan
facility: Gifu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Nishi Eye Hospital
city: Osaka
country: Japan
facility: Adachi Eye Clinic
city: Osaka
country: Japan
facility: Osaka Welfare Pension Hospital
city: Shizuoka
country: Japan
facility: Nanba Opthalmology
city: Sugita
country: Japan
facility: Sugita Eye Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: