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Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Primary Purpose

Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

bimatoprost 0.03% eye drops

travoprost 0.004% eye drops

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:

Glaucoma or ocular hypertension in both eyes
Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering
Best-corrected visual acuity of 20/100 or better in each eye
Visual field within 6 months of study entry

Exclusion Criteria:

Secondary glaucoma
Active intraocular inflammation or macular edema
Intraocular surgery or laser surgery within the past 3 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)

Intraocular Pressure

Secondary Outcome Measures

Tolerability - Conjunctival Hyperemia

Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)

Full Information

NCT ID

NCT00440011

First Posted

February 22, 2007

Last Updated

April 10, 2019

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00440011

Brief Title

Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Allergan

4. Oversight

5. Study Description

Brief Summary

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

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 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

266 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

bimatoprost 0.03% eye drops

Other Intervention Name(s)

Lumigan®

Intervention Description

bimatoprost 0.03% 1 drop nightly for 3 months

Intervention Type

Drug

Intervention Name(s)

travoprost 0.004% eye drops

Other Intervention Name(s)

Travatan®

Intervention Description

travoprost 0.004% 1 drop nightly for 3 months

Primary Outcome Measure Information:

Title

Intraocular Pressure (IOP)

Description

Intraocular Pressure

Time Frame

Month 3

Secondary Outcome Measure Information:

Title

Tolerability - Conjunctival Hyperemia

Description

Conjunctival Hyperemia: Number of participants with at least 1 grade increase in severity from baseline. A five grade scale from 0 to 3 (0 = none, +0.5 = trace, 1 = mild, 2 = moderate, 3 = severe)

Time Frame

Month 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Glaucoma or ocular hypertension in both eyes Currently being treated with latanoprost 0.005% daily and in need of additional IOP-lowering Best-corrected visual acuity of 20/100 or better in each eye Visual field within 6 months of study entry Exclusion Criteria: Secondary glaucoma Active intraocular inflammation or macular edema Intraocular surgery or laser surgery within the past 3 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Affairs

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

San Diego

State/Province

California

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19726422

Citation

Kammer JA, Katzman B, Ackerman SL, Hollander DA. Efficacy and tolerability of bimatoprost versus travoprost in patients previously on latanoprost: a 3-month, randomised, masked-evaluator, multicentre study. Br J Ophthalmol. 2010 Jan;94(1):74-9. doi: 10.1136/bjo.2009.158071. Epub 2009 Sep 1.

Results Reference

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Bimatoprost 0.03% Versus Travoprost 0.004% in Patients Currently on Latanoprost 0.005%

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