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24-hour IOP-lowering Effect of 0.01% Bimatoprost

Primary Purpose

Intraocular Pressure, Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
0.01% bimatoprost
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Pressure

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease

Sites / Locations

  • UCSD Shiley Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.01% bimatoprost

Arm Description

bimatoprost 0.01% one time per day at bedtime for 4 weeks.

Outcomes

Primary Outcome Measures

Nocturnal Intraocular Pressure (IOP) Change
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2011
Last Updated
May 19, 2014
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01271686
Brief Title
24-hour IOP-lowering Effect of 0.01% Bimatoprost
Official Title
24-hour IOP-lowering Effect of 0.01% Bimatoprost
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension
Detailed Description
Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP). Design Prospective, open-label experimental study. Setting Single tertiary ophthalmic clinic. Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years). Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions. Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.01% bimatoprost
Arm Type
Experimental
Arm Description
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
0.01% bimatoprost
Other Intervention Name(s)
Lumigan 0.01%
Intervention Description
0.01% bimatoprost once in the evening for 4 weeks
Primary Outcome Measure Information:
Title
Nocturnal Intraocular Pressure (IOP) Change
Description
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary open-angle glaucoma or ocular hypertension Exclusion Criteria: Women of childbearing potential previous glaucoma surgery presence of other eye disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Liu, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Shiley Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22918671
Citation
Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.
Results Reference
result
Links:
URL
http://bmjopen.bmj.com/content/2/4/e001106.full
Description
Open access publication

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24-hour IOP-lowering Effect of 0.01% Bimatoprost

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