A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Overview

This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and 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: June 24, 2011

Interventions

  • Drug: Bimatoprost 0.03%
    • Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Arms, Groups and Cohorts

  • Experimental: Bimatoprost 0.03%
    • Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Pressure (IOP) in the Study Eye
    • Time Frame: Month 3
    • IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).

Secondary Measures

  • Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
    • Time Frame: 3 Months
    • Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of open-angle glaucoma or ocular hypertension – No use of Lumigan® in the past 3 months Exclusion Criteria:

  • Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

References

Wang K, Xu L, Yuan Z, Yao K, Zhao J, Xu L, Fang A, Zhang M, Wu L, Ji J, Hou J, Liu Q, Sun X. Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China. BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.

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