Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT00300443
Collaborator
(none)
561
1
18
31.2
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular hypertension
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
561 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Jun 1, 2007
Actual Study Completion Date
:
Jun 1, 2007
Outcome Measures
Primary Outcome Measures
- Lowering intraocular pressure (IOP) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Clinical diagnosis of glaucoma or ocular hypertension in both eyes
-
Patient requires IOP-lowering drug in both eyes
Exclusion Criteria:
-
Uncontrolled medical conditions
-
Ocular seasonal allergies within the past 2 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Newport Beach | California | United States |
Sponsors and Collaborators
- Allergan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00300443
Other Study ID Numbers:
- 192024-031
First Posted:
Mar 9, 2006
Last Update Posted:
May 30, 2011
Last Verified:
May 1, 2011