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

Primary Purpose

Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bimatoprost 0.01% ophthalmic solution

Bimatoprost 0.015% formulation 1 ophthalmic solution

Bimatoprost 0.015% formulation 2 ophthalmic solution

Bimatoprost 0.02% ophthalmic solution

Bimatoprost 0.03% ophthalmic solution

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Uncontrolled systemic disease
Known allergy or hypersensitivity to bimatoprost

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Bimatoprost 0.01% ophthalmic solution

Bimatoprost 0.015% formulation 1 ophthalmic solution

Bimatoprost 0.015% formulation 2 ophthalmic solution

Bimatoprost 0.02% ophthalmic solution

Bimatoprost 0.03% ophthalmic solution

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP)

Secondary Outcome Measures

Patient Comfort

Patient Satisfaction

Treatment Preference

Full Information

NCT ID

NCT00652496

First Posted

April 1, 2008

Last Updated

April 1, 2008

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00652496

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Allergan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Bimatoprost 0.01% ophthalmic solution

Arm Title

Arm Type

Experimental

Arm Description

Bimatoprost 0.015% formulation 1 ophthalmic solution

Arm Title

Arm Type

Experimental

Arm Description

Bimatoprost 0.015% formulation 2 ophthalmic solution

Arm Title

Arm Type

Experimental

Arm Description

Bimatoprost 0.02% ophthalmic solution

Arm Title

Arm Type

Active Comparator

Arm Description

Bimatoprost 0.03% ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

Bimatoprost 0.01% ophthalmic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bimatoprost 0.015% formulation 1 ophthalmic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bimatoprost 0.015% formulation 2 ophthalmic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bimatoprost 0.02% ophthalmic solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bimatoprost 0.03% ophthalmic solution

Other Intervention Name(s)

LUMIGAN®

Intervention Description

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

Primary Outcome Measure Information:

Title

Intraocular pressure (IOP)

Time Frame

Day 5

Secondary Outcome Measure Information:

Title

Patient Comfort

Time Frame

Days 1-4

Title

Patient Satisfaction

Time Frame

Day 5

Title

Treatment Preference

Time Frame

Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ocular hypertension or glaucoma in both eyes Require IOP-lowering therapy in each eye Exclusion Criteria: Uncontrolled systemic disease Known allergy or hypersensitivity to bimatoprost

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

Wenatchee

State/Province

Washington

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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