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Completed

NCT Number: NCT01833741

A Study of LUMIGAN® RC in the Clinical Setting

This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.

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Key information

Conditions

Glaucoma, Primary Open Angle Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barrie, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
  • Determined by the treating physician to require treatment with LUMIGAN® RC

Exclusion criteria

  • None

Treatment and study plan

Bimatoprost 0.01%

Drug

Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Other names: LUMIGAN® RC

Primary outcomes

  1. Percentage of Treatment-Naive Patients With Ocular Hyperemia

    Time frame: Week 12

    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). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.

  2. Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia

    Time frame: Week 12

    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). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.

  3. Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia

    Time frame: Week 12

    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). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.

Secondary outcomes

  1. Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients

    Time frame: Baseline, 12 Weeks

    IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  2. Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients

    Time frame: Baseline, 12 Weeks

    IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  3. Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy

    Time frame: Baseline, 12 Weeks

    IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).

  4. Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients

    Time frame: Baseline, Week 6, Week 12

    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).

  5. Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients

    Time frame: Baseline, Week 6, Week 12

    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).

  6. Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy

    Time frame: Baseline, Week 6, Week 12

    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).

  7. Percentage of Patients Discontinuing Due to Ocular Adverse Events

    Time frame: 12 Weeks

    Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 17, 2013
Registry last updated
Sep 26, 2013

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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