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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xalatan | Experimental |
| |
| Xalacom | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xalatan | Drug | latanoprost 0.005%, one rop once daily in evening |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Intraocular Pressure (IOP) From Baseline to Week 8 | Value at Week 8 minus value at baseline | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of IOP From Baseline to Week 4 | Value at Week 4 minus value at baseline | Baseline to Week 4 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nomura Eye Clinic | Ichinomiya | Aichi-ken | 491-0837 | Japan | ||
| Matsusura Eye Clinic |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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300 subjects were treated with Xalatan in Run-in period. (Run-in period: subjects treated with Xalatan (0.005% latanoprost eye drop), one drop, once daily in the evening (20:00-23:00).) Of these, 289 subjects were assigned to groups (144 in KP2035 group and 145 in Xalatan group).
55 centers in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | KP2035 Group | Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00). |
| FG001 | Xalatan Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Xalacom |
| Drug |
latanoprost 0.005% adn timolol 0.5%, one drop, once daily |
|
| 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 | 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 | Baseline to Week 8 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | KP2035 Group | Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00). |
| BG001 | Xalatan Group | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Intraocular Pressure (IOP) From Baseline to Week 8 | Value at Week 8 minus value at baseline | The primary efficacy analysis population was the Intent-to-treat population (ITT) which consisted of all subjects treated with the study drug as randomized. If there were any missing IOP values at Week 8, the data were supplemented by LOCF (Last Observation Carried Forward) using data at Week 4. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline to Week 8 |
|
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| ||||||||||||||||||||||||||||
| Secondary | Change of IOP From Baseline to Week 4 | Value at Week 4 minus value at baseline | ITT | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Count of Participants | Participants | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Count of Participants | Participants | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Count of Participants | Participants | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Count of Participants | Participants | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Count of Participants | Participants | 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 | The efficacy analysis population was ITT. If there were any missing IOP values at Week 8, the data were supplemented by LOCF using data at Week 4. | Posted | Count of Participants | Participants | Week 8 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KP2035 Group | Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00). | 0 | 144 | 1 | 144 | 51 | 144 |
| EG001 | Xalatan Group | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). | 0 | 145 | 2 | 145 | 29 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Ulcerative keratitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Cerumen impaction | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Abnormal sensation in eye | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
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| Glucose urine present | Investigations | MedDRA v10.0 | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Foreign body sensation in eye | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Meibomianitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Scleritis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Growth of eyelashes | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Dry eye | Eye disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA v10.0 | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA v10.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA v10.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| C571753 | Xalacom |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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