24-hour IOP-lowering Effect of 0.01% Bimatoprost

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01271686
First received: January 6, 2011
Last updated: May 19, 2014
Last verified: May 2014

January 6, 2011
May 19, 2014
January 2011
October 2012   (final data collection date for primary outcome measure)
Nocturnal Intraocular Pressure (IOP) Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
mean IOP for 24-hour period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01271686 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
24-hour IOP-lowering Effect of 0.01% Bimatoprost
24-hour IOP-lowering Effect of 0.01% Bimatoprost

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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intraocular Pressure
  • Glaucoma
  • Ocular Hypertension
Drug: 0.01% bimatoprost
0.01% bimatoprost once in the evening for 4 weeks
Other Name: Lumigan 0.01%
Experimental: 0.01% bimatoprost
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Intervention: Drug: 0.01% bimatoprost
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). pii: e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01271686
UCSD 101705 bimatoprost
Yes
John Liu, PhD, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: John Liu, PhD University of California, San Diego
University of California, San Diego
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP