Expired Study
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La Jolla, California 92093


Purpose:

This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension


Criteria:

Inclusion Criteria: - primary open-angle glaucoma or ocular hypertension Exclusion Criteria: - Women of childbearing potential previous glaucoma surgery presence of other eye disease


Study is Available At:


Original ID:

UCSD 101705 bimatoprost


NCT ID:

NCT01271686


Secondary ID:


Study Acronym:


Brief Title:

24-hour Effect of Bimatoprost


Official Title:

24-hour IOP-lowering Effect of 0.01% Bimatoprost


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Diego


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Study Dates

Start Date:January 2011
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 9, 2012
First Received Date:January 6, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:mean IOP for 24-hour period
Time Frame:4 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:0.01% bimatoprost
Description:0.01% bimatoprost once in the evening for 4 weeks
Arm Name:0.01% bimatoprost
Other Name:Lumigan 0.01%

Study Arms

Study Arm Type:Experimental
Arm Name:0.01% bimatoprost

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Diego

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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