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

NCT00651859 | Completed Phase 2

• 1 other identifier: 192024-024
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Day 14

Secondary Outcomes (1)

• IOP

  Days 2 and 7

Study Arms (3)

1

EXPERIMENTAL

Bimatoprost 0.01% Ophthalmic Solution

Drug: Bimatoprost 0.01% Ophthalmic Solution

2

EXPERIMENTAL

Bimatoprost 0.03% Ophthalmic Solution

Drug: Bimatoprost 0.03% Ophthalmic Solution

3

PLACEBO COMPARATOR

Bimatoprost Vehicle Ophthalmic Solution

Drug: Bimatoprost Vehicle Ophthalmic Solution

Interventions

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

1

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

Also known as: LUMIGAN®

2

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

3

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

San Francisco, California, United States

Location

Related Links

• Link to Clinical Trial Results

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Bimatoprost; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 3, 2008
• Study Start: November 1, 2002
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (1)