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

Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383019
• Other study ID #: A6641050
• Status: Completed
• Phase: Phase 3
• Start date: November 14, 2006
• Est. completion date: October 1, 2007

Study information

• Verified date: August 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 1, 2007
• Est. primary completion date: October 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Xalatan
latanoprost 0.005%, one rop once daily in evening
• Xalacom
latanoprost 0.005% adn timolol 0.5%, one drop, once daily

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-ku	Tokyo
Japan	Tokyo Metropolitan Police Hospital	Chiyoda	Tokyo
Japan	Ochanomizu Inoue Eye Clinic	Chiyoda-ku	Tokyo
Japan	Hanasaki Eye Clinic	Fuji	Shizuoka
Japan	Nakajima Eye Clinic	Fuji	Shizuoka
Japan	Lumine Hatano Eye Clinic	Fujisawa	Kanagawa
Japan	Hayashi Eye Hospital	Fujuoka
Japan	Hayashi Tennjin Eye Clinic	Fukuoka
Japan	Kato Eye Clinic	Fukuoka
Japan	Ohshima Hospital of Opthalmology	Fukuoka
Japan	Gifu University Hospital	Gifu
Japan	Keio Hachioji Matsumoto Eye Clinic	Hachioji	Tokyo
Japan	Manabe Clinic	Hamura	Tokyo
Japan	Hiroshima University Hospital	Hiroshima
Japan	Matsusura Eye Clinic	Ichinomiya	Aichi
Japan	Nomura Eye Clinic	Ichinomiya	Aichi
Japan	Tanino clinic	Kamakura	Kanagawa
Japan	Kanazawa university hospital	Kanazawa	Ishikawa
Japan	Tokyo Sugita Eye Center	Katsushika-ku	Tokyo
Japan	Kiyosenomori Hospital	Kiyose	Tokyo
Japan	Miyazaki Eye Clinic	Koto-ku	Tokyo
Japan	Kobe University Hospital	Koube	Hyogo
Japan	Hayashi Eye Clinic	Kumagaya	Saitama
Japan	Takase Ganka Tairamachi Clinic	Meguro	Tokyo
Japan	Ohashi Eye Clinic	Meguro-ku	Tokyo
Japan	Yoshimura Eye & Internal Medical Clinic	Mishima	Shizuoka
Japan	Miyata Eye Hospital	Miyakonojo	Miyazaki
Japan	Kunitoshi Eye Clinic	Musashino	Tokyo
Japan	Shimizu Eye Clinic	Musashino	Tokyo
Japan	Suzuki Eye Clinic	Nagoya	Aichi
Japan	TANABE Eye Clinic	Nagoya	Aichi
Japan	Yasuma Eye Clinic	Nagoya	Aichi
Japan	Mitsuhashi Eye Clinic	Narashino	Chiba
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Adachi Eye Clinic	Osaka
Japan	Nishi Eye Hospital	Osaka
Japan	Osaka Welfare Pension Hospital	Osaka
Japan	WAKABA Eye Clinic	Ota-ku	Tokyo
Japan	Aoki eye clinic	Sagamihara	Kanagawa
Japan	Fujita Eye Clinic	Sapporo	Kokkaido
Japan	Kaimeido Eye Clinic	Sapporo	Hokkaido
Japan	Ohtsuka Eye Clinic	Sapporo	Hokkaido
Japan	Ohyachi Kyouritsu Eye Clinic	Sapporo	Hokkaido
Japan	Sasamoto Eye Clinic	Sapporo	Hokkaido
Japan	Seijo Clinic	Setagaya	Tokyo
Japan	Yotsuya Shirato Ganka	Shinjuku	Tokyo
Japan	Nanba Opthalmology	Shizuoka
Japan	Sugita Eye Hospital	Sugita
Japan	Muramatsu Ganka Clinic	Susono	Shizuoka
Japan	Tachihi Bill clinic	Tachikawa	Tokyo
Japan	Ueno Eye Clinic	Taito-ku	Tokyo
Japan	Hiraoka Eye Clinic	Tokorozawa	Saitama
Japan	Chihara Eye Clinic	Uji	Kyoto
Japan	Kikuna Yuda Eye Clinic	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Intraocular Pressure (IOP) From Baseline to Week 8	Value at Week 8 minus value at baseline	Baseline to Week 8
Secondary	Change of IOP From Baseline to Week 4	Value at Week 4 minus value at baseline	Baseline to Week 4
Secondary	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	Week 8
Secondary	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	Week 8
Secondary	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	Baseline to Week 8
Secondary	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	Week 8
Secondary	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	Baseline to Week 8
Secondary	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	Baseline to Week 8
Secondary	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	Week 8

External Links

•   To obtain contact information for a study center near you, click here.