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

NCT ID: NCT00383019

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-14
• Study Completion Date: 2007-10-01

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.

Conditions

Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Xalatan

Group Type: EXPERIMENTAL

Xalatan

Intervention Type: DRUG

latanoprost 0.005%, one rop once daily in evening

Xalacom

Group Type: EXPERIMENTAL

Xalacom

Intervention Type: DRUG

latanoprost 0.005% adn timolol 0.5%, one drop, once daily

Interventions

Xalatan

latanoprost 0.005%, one rop once daily in evening

Intervention Type: DRUG

Xalacom

latanoprost 0.005% adn timolol 0.5%, one drop, once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Nomura Eye Clinic

Ichinomiya, Aichi-ken, Japan

Matsusura Eye Clinic

Ichinomiya, Aichi-ken, Japan

Yasuma Eye Clinic

Nagoya, Aichi-ken, Japan

TANABE Eye Clinic

Nagoya, Aichi-ken, Japan

Suzuki Eye Clinic

Nagoya, Aichi-ken, Japan

Mitsuhashi Eye Clinic

Narashino, Chiba, Japan

Ohtsuka Eye Clinic

Sapporo, Hokkaido, Japan

Sasamoto Eye Clinic

Sapporo, Hokkaido, Japan

Ohyachi Kyouritsu Eye Clinic

Sapporo, Hokkaido, Japan

Kaimeido Eye Clinic

Sapporo, Hokkaido, Japan

Kobe University Hospital

Koube, Hyōgo, Japan

Kanazawa university hospital

Kanazawa, Ishikawa-ken, Japan

Lumine Hatano Eye Clinic

Fujisawa, Kanagawa, Japan

Tanino clinic

Kamakura, Kanagawa, Japan

Aoki eye clinic

Sagamihara, Kanagawa, Japan

Kikuna Yuda Eye Clinic

Yokohama, Kanagawa, Japan

Fujita Eye Clinic

Sapporo, Kokkaido, Japan

Chihara Eye Clinic

Uji, Kyoto, Japan

Miyata Eye Hospital

Miyakonojō, Miyazaki, Japan

Hayashi Eye Clinic

Kumagaya, Saitama, Japan

Hiraoka Eye Clinic

Tokorozawa, Saitama, Japan

Hanasaki Eye Clinic

Fuji, Shizuoka, Japan

Nakajima Eye Clinic

Fuji, Shizuoka, Japan

Yoshimura Eye & Internal Medical Clinic

Mishima, Shizuoka, Japan

Muramatsu Ganka Clinic

Susono, Shizuoka, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Police Hospital

Chiyoda City, Tokyo, Japan

Ochanomizu Inoue Eye Clinic

Chiyoda-ku, Tokyo, Japan

Keio Hachioji Matsumoto Eye Clinic

Hachiōji, Tokyo, Japan

Manabe Clinic

Hamura, Tokyo, Japan

Tokyo Sugita Eye Center

Katsushika-ku, Tokyo, Japan

Kiyosenomori Hospital

Kiyose, Tokyo, Japan

Miyazaki Eye Clinic

Koto-ku, Tokyo, Japan

Takase Ganka Tairamachi Clinic

Meguro City, Tokyo, Japan

Ohashi Eye Clinic

Meguro-ku, Tokyo, Japan

Kunitoshi Eye Clinic

Musashino, Tokyo, Japan

Shimizu Eye Clinic

Musashino, Tokyo, Japan

WAKABA Eye Clinic

Ōta-ku, Tokyo, Japan

Seijo Clinic

Setagaya City, Tokyo, Japan

Yotsuya Shirato Ganka

Shinjuku, Tokyo, Japan

Tachihi Bill clinic

Tachikawa, Tokyo, Japan

Ueno Eye Clinic

Taito-ku, Tokyo, Japan

Hayashi Eye Hospital

Fujuoka, , Japan

Hayashi Tennjin Eye Clinic

Fukuoka, , Japan

Ohshima Hospital of Opthalmology

Fukuoka, , Japan

Kato Eye Clinic

Fukuoka, , Japan

Gifu University Hospital

Gifu, , Japan

Hiroshima University Hospital

Hiroshima, , Japan

Niigata University Medical and Dental Hospital

Niigata, , Japan

Nishi Eye Hospital

Osaka, , Japan

Adachi Eye Clinic

Osaka, , Japan

Osaka Welfare Pension Hospital

Osaka, , Japan

Nanba Opthalmology

Shizuoka, , Japan

Sugita Eye Hospital

Sugita, , Japan

Countries

Japan

Related Links

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

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Other Identifiers

A6641050

Identifier Type: -

Identifier Source: org_study_id