Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

NCT00652496 | Completed Phase 2

• 1 other identifier: 192024-030
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure (IOP)

  Day 5

Secondary Outcomes (3)

• Patient Comfort

  Days 1-4

• Patient Satisfaction

  Day 5

• Treatment Preference

  Day 5

Study Arms (5)

1

EXPERIMENTAL

Bimatoprost 0.01% ophthalmic solution

Drug: Bimatoprost 0.01% ophthalmic solution

2

EXPERIMENTAL

Bimatoprost 0.015% formulation 1 ophthalmic solution

Drug: Bimatoprost 0.015% formulation 1 ophthalmic solution

3

EXPERIMENTAL

Bimatoprost 0.015% formulation 2 ophthalmic solution

Drug: Bimatoprost 0.015% formulation 2 ophthalmic solution

4

EXPERIMENTAL

Bimatoprost 0.02% ophthalmic solution

Drug: Bimatoprost 0.02% ophthalmic solution

5

ACTIVE COMPARATOR

Bimatoprost 0.03% ophthalmic solution

Drug: Bimatoprost 0.03% ophthalmic solution

Interventions

Bimatoprost 0.01% ophthalmic solution DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

1

Bimatoprost 0.015% formulation 1 ophthalmic solution DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

2

Bimatoprost 0.015% formulation 2 ophthalmic solution DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

3

Bimatoprost 0.02% ophthalmic solution DRUG

One drop in one eye, once daily in the morning for 4 consecutive days, the other eye received the active control eye drop

4

Bimatoprost 0.03% ophthalmic solution DRUG

Bimatoprost 0.03% ophthalmic solution, one drop in one eye, once daily in the morning for 4 consecutive days, the other eye received one drop of any of the 4 study drugs

Also known as: LUMIGAN®

5

Eligibility Criteria

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

You may qualify if:

• Ocular hypertension or glaucoma in both eyes
• Require IOP-lowering therapy in each eye

You may not qualify if:

• Uncontrolled systemic disease
• Known allergy or hypersensitivity to bimatoprost

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Wenatchee, Washington, United States

Location

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: January 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (1)