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Completed

NCT Number: NCT02061683

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

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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bimatoprost 0.03%

Drug

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

Other names: LUMIGAN®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: LOTUS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 13, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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