24-hour IOP-lowering Effect of 0.01% Bimatoprost

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2012

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Nocturnal Intraocular Pressure (IOP) Change
    • Time Frame: 4 weeks
    • Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

Participating in This Clinical Trial

Inclusion Criteria

  • primary open-angle glaucoma or ocular hypertension Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Liu, PhD, Adjunct Professor – University of California, San Diego
  • Overall Official(s)
    • John Liu, PhD, Principal Investigator, University of California, San Diego

Citations Reporting on Results

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.

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