A Study Comparing Xalacom And Xalatan In Patients With Primary Open Angle Glaucoma (POAG) Or Ocular Hypertension (OH).
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Xalatan
|
Drug: Xalatan
latanoprost 0.005%, one rop once daily in evening
|
Experimental: Xalacom
|
Drug: Xalacom
latanoprost 0.005% adn timolol 0.5%, one drop, once daily
|
Outcome Measures
Primary Outcome Measures
- Change of Intraocular Pressure (IOP) From Baseline to Week 8 [Baseline to Week 8]
Value at Week 8 minus value at baseline
Secondary Outcome Measures
- Change of IOP From Baseline to Week 4 [Baseline to Week 4]
Value at Week 4 minus value at baseline
- Number of Subjects With an IOP of <=15 mmHg at Week 8 [Week 8]
Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8
- Number of Subjects With an IOP of <=16 mmHg at Week 8 [Week 8]
Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8
- Percent Change of IOP From Baseline to Week 8 [Baseline to Week 8]
Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100
- Number of Subjects With an IOP of <=18 mmHg at Week 8 [Week 8]
Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8
- Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 [Baseline to Week 8]
Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline
- Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 [Baseline to Week 8]
Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline
- Number of Subjects With an IOP of <=17 mmHg at Week 8 [Week 8]
Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Nomura Eye Clinic | Ichinomiya | Aichi | Japan | 491-0837 |
2 | Matsusura Eye Clinic | Ichinomiya | Aichi | Japan | 491-0858 |
3 | Yasuma Eye Clinic | Nagoya | Aichi | Japan | 460-0011 |
4 | TANABE Eye Clinic | Nagoya | Aichi | Japan | 466-0054 |
5 | Suzuki Eye Clinic | Nagoya | Aichi | Japan | 467-0806 |
6 | Mitsuhashi Eye Clinic | Narashino | Chiba | Japan | 275-0016 |
7 | Ohtsuka Eye Clinic | Sapporo | Hokkaido | Japan | 001-0016 |
8 | Sasamoto Eye Clinic | Sapporo | Hokkaido | Japan | 001-0039 |
9 | Ohyachi Kyouritsu Eye Clinic | Sapporo | Hokkaido | Japan | 004-0041 |
10 | Kaimeido Eye Clinic | Sapporo | Hokkaido | Japan | 062-0020 |
11 | Kobe University Hospital | Koube | Hyogo | Japan | 650-0017 |
12 | Kanazawa university hospital | Kanazawa | Ishikawa | Japan | 920-0934 |
13 | Lumine Hatano Eye Clinic | Fujisawa | Kanagawa | Japan | 251-0052 |
14 | Tanino clinic | Kamakura | Kanagawa | Japan | 248-0035 |
15 | Aoki eye clinic | Sagamihara | Kanagawa | Japan | 228-0806 |
16 | Kikuna Yuda Eye Clinic | Yokohama | Kanagawa | Japan | 222-0011 |
17 | Fujita Eye Clinic | Sapporo | Kokkaido | Japan | 003-0062 |
18 | Chihara Eye Clinic | Uji | Kyoto | Japan | 611-0043 |
19 | Miyata Eye Hospital | Miyakonojo | Miyazaki | Japan | 885-0051 |
20 | Hayashi Eye Clinic | Kumagaya | Saitama | Japan | 360-0843 |
21 | Hiraoka Eye Clinic | Tokorozawa | Saitama | Japan | 359-1116 |
22 | Hanasaki Eye Clinic | Fuji | Shizuoka | Japan | 416-0952 |
23 | Nakajima Eye Clinic | Fuji | Shizuoka | Japan | 419-0204 |
24 | Yoshimura Eye & Internal Medical Clinic | Mishima | Shizuoka | Japan | 411-0824 |
25 | Muramatsu Ganka Clinic | Susono | Shizuoka | Japan | 410-1102 |
26 | The University of Tokyo Hospital | Bunkyo-ku | Tokyo | Japan | 113-8655 |
27 | Ochanomizu Inoue Eye Clinic | Chiyoda-ku | Tokyo | Japan | 101-0062 |
28 | Tokyo Metropolitan Police Hospital | Chiyoda | Tokyo | Japan | 102-8161 |
29 | Keio Hachioji Matsumoto Eye Clinic | Hachioji | Tokyo | Japan | 192-0046 |
30 | Manabe Clinic | Hamura | Tokyo | Japan | 205-0001 |
31 | Tokyo Sugita Eye Center | Katsushika-ku | Tokyo | Japan | 125-0041 |
32 | Kiyosenomori Hospital | Kiyose | Tokyo | Japan | 204-0021 |
33 | Miyazaki Eye Clinic | Koto-ku | Tokyo | Japan | 136-0076 |
34 | Ohashi Eye Clinic | Meguro-ku | Tokyo | Japan | 153-0043 |
35 | Takase Ganka Tairamachi Clinic | Meguro | Tokyo | Japan | 152-0032 |
36 | Kunitoshi Eye Clinic | Musashino | Tokyo | Japan | 180-0004 |
37 | Shimizu Eye Clinic | Musashino | Tokyo | Japan | 180-0022 |
38 | WAKABA Eye Clinic | Ota-ku | Tokyo | Japan | 144-052 |
39 | Seijo Clinic | Setagaya | Tokyo | Japan | 157-0066 |
40 | Yotsuya Shirato Ganka | Shinjuku | Tokyo | Japan | 160-0004 |
41 | Tachihi Bill clinic | Tachikawa | Tokyo | Japan | 190-0003 |
42 | Ueno Eye Clinic | Taito-ku | Tokyo | Japan | 110-015 |
43 | Hayashi Eye Hospital | Fujuoka | Japan | 812-0011 | |
44 | Hayashi Tennjin Eye Clinic | Fukuoka | Japan | 810-0002 | |
45 | Ohshima Hospital of Opthalmology | Fukuoka | Japan | 812-0036 | |
46 | Kato Eye Clinic | Fukuoka | Japan | 814-0133 | |
47 | Gifu University Hospital | Gifu | Japan | 501-1194 | |
48 | Hiroshima University Hospital | Hiroshima | Japan | 734-8551 | |
49 | Niigata University Medical and Dental Hospital | Niigata | Japan | 951-8122 | |
50 | Nishi Eye Hospital | Osaka | Japan | 537-0025 | |
51 | Adachi Eye Clinic | Osaka | Japan | 557-0044 | |
52 | Osaka Welfare Pension Hospital | Osaka | Japan | ||
53 | Nanba Opthalmology | Shizuoka | Japan | 420-0833 | |
54 | Sugita Eye Hospital | Sugita | Japan |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A6641050
Study Results
Participant Flow
Recruitment Details | 55 centers in Japan |
---|---|
Pre-assignment Detail | 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). |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Period Title: Overall Study | ||
STARTED | 144 | 145 |
COMPLETED | 139 | 143 |
NOT COMPLETED | 5 | 2 |
Baseline Characteristics
Arm/Group Title | KP2035 Group | Xalatan Group | Total |
---|---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). | Total of all reporting groups |
Overall Participants | 144 | 145 | 289 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
78
54.2%
|
77
53.1%
|
155
53.6%
|
>=65 years |
66
45.8%
|
68
46.9%
|
134
46.4%
|
Sex: Female, Male (Count of Participants) | |||
Female |
70
48.6%
|
74
51%
|
144
49.8%
|
Male |
74
51.4%
|
71
49%
|
145
50.2%
|
Region of Enrollment (Count of Participants) | |||
Japan |
144
100%
|
145
100%
|
289
100%
|
Outcome Measures
Title | Change of Intraocular Pressure (IOP) From Baseline to Week 8 |
---|---|
Description | Value at Week 8 minus value at baseline |
Time Frame | Baseline to Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Least Squares Mean (95% Confidence Interval) [mmHg] |
-2.59
|
-1.62
|
Title | Change of IOP From Baseline to Week 4 |
---|---|
Description | Value at Week 4 minus value at baseline |
Time Frame | Baseline to Week 4 |
Outcome Measure Data
Analysis Population Description |
---|
ITT |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Least Squares Mean (95% Confidence Interval) [mmHg] |
-2.50
|
-1.17
|
Title | Number of Subjects With an IOP of <=15 mmHg at Week 8 |
---|---|
Description | Number of subjects who achieved IOP reduction to 15 mmHg or below at Week 8 |
Time Frame | Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Count of Participants [Participants] |
36
25%
|
13
9%
|
Title | Number of Subjects With an IOP of <=16 mmHg at Week 8 |
---|---|
Description | Number of subjects who achieved IOP reduction to 16 mmHg or below at Week 8 |
Time Frame | Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Count of Participants [Participants] |
60
41.7%
|
35
24.1%
|
Title | Percent Change of IOP From Baseline to Week 8 |
---|---|
Description | Value at Week 8 minus value at baseline was divided by baseline value, then multiplied by 100 |
Time Frame | Baseline to Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Least Squares Mean (95% Confidence Interval) [percent change] |
-12.67
|
-7.69
|
Title | Number of Subjects With an IOP of <=18 mmHg at Week 8 |
---|---|
Description | Number of subjects who achieved IOP reduction to 18 mmHg or below at Week 8 |
Time Frame | Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Count of Participants [Participants] |
105
72.9%
|
91
62.8%
|
Title | Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8 |
---|---|
Description | Number of subjects whose IOP were reduced by 2 mmHg or more at Week 8 from baseline |
Time Frame | Baseline to Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Count of Participants [Participants] |
95
66%
|
65
44.8%
|
Title | Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8 |
---|---|
Description | Number of subjects whose IOP were reduced by 3 mmHg or more at Week 8 from baseline |
Time Frame | Baseline to Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Count of Participants [Participants] |
66
45.8%
|
40
27.6%
|
Title | Number of Subjects With an IOP of <=17 mmHg at Week 8 |
---|---|
Description | Number of subjects who achieved IOP reduction to 17 mmHg or below at Week 8 |
Time Frame | Week 8 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | KP2035 Group | Xalatan Group |
---|---|---|
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). |
Measure Participants | 144 | 145 |
Count of Participants [Participants] |
83
57.6%
|
60
41.4%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||
Arm/Group Title | KP2035 Group | Xalatan Group | ||
Arm/Group Description | 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). | Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00). | ||
All Cause Mortality |
||||
KP2035 Group | Xalatan Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/144 (0%) | 0/145 (0%) | ||
Serious Adverse Events |
||||
KP2035 Group | Xalatan Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/144 (0.7%) | 2/145 (1.4%) | ||
Gastrointestinal disorders | ||||
Inflammatory bowel disease | 1/144 (0.7%) | 0/145 (0%) | ||
Inguinal hernia | 0/144 (0%) | 1/145 (0.7%) | ||
Infections and infestations | ||||
Pneumonia | 0/144 (0%) | 1/145 (0.7%) | ||
Pyelitis | 0/144 (0%) | 1/145 (0.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
KP2035 Group | Xalatan Group | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 51/144 (35.4%) | 29/145 (20%) | ||
Ear and labyrinth disorders | ||||
Cerumen impaction | 1/144 (0.7%) | 0/145 (0%) | ||
Tinnitus | 0/144 (0%) | 1/145 (0.7%) | ||
Eye disorders | ||||
Conjunctivitis | 2/144 (1.4%) | 1/145 (0.7%) | ||
Retinal tear | 1/144 (0.7%) | 0/145 (0%) | ||
Eye irritation | 25/144 (17.4%) | 2/145 (1.4%) | ||
Vitreous floaters | 1/144 (0.7%) | 0/145 (0%) | ||
Keratitis | 3/144 (2.1%) | 0/145 (0%) | ||
Ulcerative keratitis | 1/144 (0.7%) | 0/145 (0%) | ||
Abnormal sensation in eye | 1/144 (0.7%) | 1/145 (0.7%) | ||
Conjunctival hyperaemia | 2/144 (1.4%) | 3/145 (2.1%) | ||
Eye discharge | 1/144 (0.7%) | 0/145 (0%) | ||
Vision blurred | 1/144 (0.7%) | 0/145 (0%) | ||
Punctate keratitis | 2/144 (1.4%) | 4/145 (2.8%) | ||
Eye pain | 0/144 (0%) | 2/145 (1.4%) | ||
Foreign body sensation in eye | 0/144 (0%) | 1/145 (0.7%) | ||
Conjunctival haemorrhage | 0/144 (0%) | 1/145 (0.7%) | ||
Meibomianitis | 0/144 (0%) | 1/145 (0.7%) | ||
Scleritis | 0/144 (0%) | 1/145 (0.7%) | ||
Growth of eyelashes | 0/144 (0%) | 2/145 (1.4%) | ||
Blepharitis | 0/144 (0%) | 1/145 (0.7%) | ||
Dry eye | 0/144 (0%) | 1/145 (0.7%) | ||
Gastrointestinal disorders | ||||
Diarrhoea | 1/144 (0.7%) | 0/145 (0%) | ||
Toothache | 0/144 (0%) | 1/145 (0.7%) | ||
Dental caries | 0/144 (0%) | 1/145 (0.7%) | ||
Constipation | 1/144 (0.7%) | 0/145 (0%) | ||
Gastrointestinal disorder | 1/144 (0.7%) | 0/145 (0%) | ||
Infections and infestations | ||||
Nasopharyngitis | 6/144 (4.2%) | 2/145 (1.4%) | ||
Tinea pedis | 1/144 (0.7%) | 0/145 (0%) | ||
Pharyngitis | 1/144 (0.7%) | 0/145 (0%) | ||
Cystitis | 0/144 (0%) | 1/145 (0.7%) | ||
Investigations | ||||
Glucose urine present | 1/144 (0.7%) | 0/145 (0%) | ||
Blood pressure increased | 0/144 (0%) | 1/145 (0.7%) | ||
Metabolism and nutrition disorders | ||||
Gout | 0/144 (0%) | 1/145 (0.7%) | ||
Musculoskeletal and connective tissue disorders | ||||
Pain in extremity | 1/144 (0.7%) | 0/145 (0%) | ||
Back pain | 0/144 (0%) | 1/145 (0.7%) | ||
Musculoskeletal stiffness | 0/144 (0%) | 1/145 (0.7%) | ||
Osteoporosis | 0/144 (0%) | 1/145 (0.7%) | ||
Nervous system disorders | ||||
Headache | 0/144 (0%) | 2/145 (1.4%) | ||
Dizziness | 0/144 (0%) | 1/145 (0.7%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Rhinitis allergic | 0/144 (0%) | 1/145 (0.7%) | ||
Upper respiratory tract inflammation | 0/144 (0%) | 1/145 (0.7%) | ||
Skin and subcutaneous tissue disorders | ||||
Eczema | 4/144 (2.8%) | 0/145 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
- A6641050