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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00383019
Collaborator
(none)
300
54
2
10.5
5.6
0.5

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

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Nov 14, 2006
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

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

  1. 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

  1. Change of IOP From Baseline to Week 4 [Baseline to Week 4]

    Value at Week 4 minus value at baseline

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00383019
Other Study ID Numbers:
  • A6641050
First Posted:
Oct 2, 2006
Last Update Posted:
Sep 8, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

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&#13;(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

1. Primary Outcome
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
2. Secondary Outcome
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
3. Secondary Outcome
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%
4. Secondary Outcome
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%
5. Secondary Outcome
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
6. Secondary Outcome
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%
7. Secondary Outcome
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%
8. Secondary Outcome
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%
9. Secondary Outcome
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

[Not Specified]

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00383019
Other Study ID Numbers:
  • A6641050
First Posted:
Oct 2, 2006
Last Update Posted:
Sep 8, 2021
Last Verified:
Aug 1, 2021