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OpenTrials
Completed

NCT Number: NCT00651859

Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension

This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension

Completed

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes

Exclusion criteria

  • Uncontrolled systemic disease
  • Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)

Treatment and study plan

Bimatoprost 0.01% ophthalmic solution

Drug

Bimatoprost 0.01% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Bimatoprost 0.03% ophthalmic solution

Drug

Bimatoprost 0.03% ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Other names: LUMIGAN®

Bimatoprost Vehicle Ophthalmic Solution

Drug

Bimatoprost vehicle ophthalmic solution 1 drop instilled in each eye once daily in the evening between 19:00 and 21:00

Primary outcomes

  1. Intraocular pressure (IOP)

    Time frame: Day 14

Secondary outcomes

  1. IOP

    Time frame: Days 2 and 7

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Apr 3, 2008
Registry last updated
Apr 3, 2008

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.

Published trials that share one or more normalized conditions with this study.