24-hour IOP-lowering Effect of 0.01% Bimatoprost

Glaucoma Clinical Trial

Official title:

24-hour IOP-lowering Effect of 0.01% Bimatoprost

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271686
• Other study ID #: UCSD 101705 bimatoprost
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2011
• Last updated: May 19, 2014
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2014
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Intraocular Pressure
• Ocular Hypertension

Intervention

Drug:
• 0.01% bimatoprost
0.01% bimatoprost once in the evening for 4 weeks

Locations

Country	Name	City	State
United States	UCSD Shiley Eye Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nocturnal Intraocular Pressure (IOP) Change	Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.	4 weeks	No

External Links

•   Open access publication