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

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ClinicalTrials.gov Identifier: NCT02061683
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : June 18, 2014
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: Bimatoprost 0.03% Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 19, 2010
Actual Primary Completion Date : June 24, 2011
Actual Study Completion Date : June 24, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Other Name: LUMIGAN®


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061683


Locations
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China
Shanghai, China
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02061683    
Other Study ID Numbers: CN-BIM-0901
First Posted: February 13, 2014    Key Record Dates
Results First Posted: June 18, 2014
Last Update Posted: April 18, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents