A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00159653

Collaborator

(none)

500

Enrollment

Locations

Duration (Months)

9.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: Xalacom Drug: Xalatan Drug: Timolol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension.

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

The mean IOP measurements obtained in the study eye at each time point []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Phoenix	Arizona	United States	85032
2	Pfizer Investigational Site	Poway	California	United States	92064
3	Pfizer Investigational Site	Redding	California	United States	96002-2122
4	Pfizer Investigational Site	Redding	California	United States	96002
5	Pfizer Investigational Site	Danbury	Connecticut	United States	06810-4004
6	Pfizer Investigational Site	Cape Coral	Florida	United States	33904
7	Pfizer Investigational Site	Lakeland	Florida	United States	33805-2440
8	Pfizer Investigational Site	Ormond Beach	Florida	United States	32174
9	Pfizer Investigational Site	Tampa	Florida	United States	33603
10	Pfizer Investigational Site	Atlanta	Georgia	United States	30322
11	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
12	Pfizer Investigational Site	Atlanta	Georgia	United States	30349
13	Pfizer Investigational Site	Morrow	Georgia	United States	30260
14	Pfizer Investigational Site	Homewood	Illinois	United States	60430
15	Pfizer Investigational Site	Overland Park	Kansas	United States	66213
16	Pfizer Investigational Site	Louisville	Kentucky	United States	40207
17	Pfizer Investigational Site	Shreveport	Louisiana	United States	71104
18	Pfizer Investigational Site	North Dartmouth	Massachusetts	United States	02747
19	Pfizer Investigational Site	Saint Joseph	Michigan	United States	49085
20	Pfizer Investigational Site	Lincoln	Nebraska	United States	68506
21	Pfizer Investigational Site	Omaha	Nebraska	United States	68198-5540
22	Pfizer Investigational Site	Newark	New Jersey	United States	07103-2499
23	Pfizer Investigational Site	Bethpage	New York	United States	11714-5701
24	Pfizer Investigational Site	New York	New York	United States	10029-6574
25	Pfizer Investigational Site	Charlotte	North Carolina	United States	28210
26	Pfizer Investigational Site	Charlotte	North Carolina	United States	28262
27	Pfizer Investigational Site	High Point	North Carolina	United States	27262
28	Pfizer Investigational Site	Matthews	North Carolina	United States	28105
29	Pfizer Investigational Site	Wilmington	North Carolina	United States	28403
30	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74104
31	Pfizer Investigational Site	Cranberry Township	Pennsylvania	United States	16066
32	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15238-3103
33	Pfizer Investigational Site	Mount Pleasant	South Carolina	United States	29464-3060
34	Pfizer Investigational Site	Mount Pleasant	South Carolina	United States	29464
35	Pfizer Investigational Site	North Charleston	South Carolina	United States	29406
36	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
37	Pfizer Investigational Site	Amarillo	Texas	United States	79106
38	Pfizer Investigational Site	Houston	Texas	United States	77030
39	Pfizer Investigational Site	Calgary	Alberta	Canada	T2T 5R6
40	Pfizer Investigational Site	Nanaimo	British Columbia	Canada	V9R 5B6
41	Pfizer Investigational Site	Moncton	New Brunswick	Canada	E1C 2N7
42	Pfizer Investigational Site	Saint John	New Brunswick	Canada	E2L 1G3
43	Pfizer Investigational Site	Saint John	New Brunswick	Canada	E2L 4W3
44	Pfizer Investigational Site	Bridgewater	Nova Scotia	Canada	B4V 3N2
45	Pfizer Investigational Site	Barrie	Ontario	Canada	L4M 4S5
46	Pfizer Investigational Site	Markham	Ontario	Canada	L6B 1A1
47	Pfizer Investigational Site	Mississauga	Ontario	Canada	L5A 4E4
48	Pfizer Investigational Site	Oakville	Ontario	Canada	L6H 3P1
49	Pfizer Investigational Site	Toronto	Ontario	Canada	M4N 3M5
50	Pfizer Investigational Site	Toronto	Ontario	Canada	M5B 1W8
51	Pfizer Investigational Site	Toronto	Ontario	Canada	M6H 2H1
52	Pfizer Investigational Site	Montreal	Quebec	Canada	H1T 2M4
53	Pfizer Investigational Site	Montreal	Quebec	Canada	H1V 1G5
54	Pfizer Investigational Site	Saskatoon	Saskatchewan	Canada	S7K 0M7
55	Pfizer Investigational Site	Saskatoon	Saskatchewan	Canada	S7K 3H3