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NCT02020512 Clinical Trial

A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension

Ocular Hypertension Clinical Trial

— LOTUSDI  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02020512
Other study ID # CN-BIM-1102
Secondary ID
Status Completed
Phase Phase 4
First received December 19, 2013
Last updated June 24, 2014
Start date July 2011
Est. completion date December 2012

Study information
Verified date June 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• 0.03% Bimatoprost
0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Intraocular Pressure (IOP) in the Study Eye IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening). Baseline, Week 5 No
See also
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Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
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