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Completed

NCT Number: NCT01157364

Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

This study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 dose strengths will be evaluated based on internal data review of each cohort. The study was planned to be conducted in 2 stages. Stage 1 was an open-label and Stage 2 was planned to be masked; however only Stage 1 was conducted.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Melbourne Eye Specialists, Fitzroy, Australia

Loading trial locations.

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

Exclusion criteria

  • Uncontrolled medical conditions
  • Anticipated wearing of contact lenses during the study

Treatment and study plan

bimatoprost 20 µg generation 2

Drug

Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.

bimatoprost 15 µg generation 2

Drug

Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

bimatoprost 10 µg generation 2

Drug

Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

bimatoprost 6 µg generation 2

Drug

Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).

bimatoprost 15 µg generation 1

Drug

Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.

bimatoprost 10 µg generation 1

Drug

Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.

bimatoprost 0.03%

Drug

One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Other names: LUMIGAN®

Primary outcomes

  1. Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye

    Time frame: Baseline, Month 24

    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Secondary outcomes

  1. Time-Matched Intraocular Pressure (IOP) in the Study Eye

    Time frame: Baseline to Month 6

    IOP is a measurement of the fluid pressure inside the study eye.

  2. Mean Diurnal IOP in the Study Eye

    Time frame: Baseline, Month 6

    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0, 2, 4, 6, and 8 and averaged to determine the mean diurnal IOP.

  3. Time to Rescue Treatment or Re-Treatment in the Study Eye

    Time frame: 24 Months

    Time to rescue treatment or the second treatment in the generation 2 groups is defined as the time between the first treatment and the second treatment in the study eye.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jul 7, 2010
Registry last updated
Mar 30, 2020

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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