Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00219596

Collaborator

(none)

240

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open Angle Ocular Hypertension	Drug: Xalacom Drug: unfixed Latanoprost and Timolol	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An 8-Week, Randomized, Open-Label, Parallel Group Study Comparing The Efficacy And Safety Of Xalacom With The Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

Study Start Date :

Jun 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Outcome Measures

Primary Outcome Measures

To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension []

Secondary Outcome Measures

To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

closed/barely open anterior chamber angle or a history of acute angel closure glaucoma
Ocular surgery within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Beijing	Beijing	China	100034
2	Pfizer Investigational Site	Beijing	Beijing	China	100730
3	Pfizer Investigational Site	Guangzhou	Guangdong	China	510060
4	Pfizer Investigational Site	Shanghai	Shanghai	China	200092
5	Pfizer Investigational Site	Xi?an	Shanxi	China	710004
6	Pfizer Investigational Site	Hangzhou	Zhejiang	China	310003
7	Pfizer Investigational Site	Hangzhou	Zhejiang	China	310009
8	Pfizer Investigational Site	Shanghai		China	200031