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Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Diagnosed with glaucoma or ocular hypertension.
  • Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

  • Any active ocular disease
  • History of any intraocular surgery or glaucoma laser surgery within 3 months
  • Contraindication to pupil dilation
  • Use of topical, periorbital, intravitreal, or systemic steroid within 3 months

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combigan® + Lumigan®

Lumigan®

Arm Description

COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)

LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes

Outcomes

Primary Outcome Measures

Mean Diurnal Intraocular Pressure (IOP) at Week 12
Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2010
Last Updated
April 10, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01170884
Brief Title
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

5. Study Description

Brief Summary
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.

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
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combigan® + Lumigan®
Arm Type
Active Comparator
Arm Description
COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
Arm Title
Lumigan®
Arm Type
Active Comparator
Arm Description
LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Intervention Type
Drug
Intervention Name(s)
fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
Other Intervention Name(s)
COMBIGAN®, LUMIGAN®
Intervention Description
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.
Intervention Type
Drug
Intervention Name(s)
bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
Other Intervention Name(s)
LUMIGAN®, Gen Teal® Mild
Intervention Description
1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes
Primary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure (IOP) at Week 12
Description
Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with glaucoma or ocular hypertension. Visual Acuity 20/100 or better in both eyes Exclusion Criteria: Any active ocular disease History of any intraocular surgery or glaucoma laser surgery within 3 months Contraindication to pupil dilation Use of topical, periorbital, intravitreal, or systemic steroid within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24707169
Citation
Myers JS, Vold S, Zaman F, Williams JM, Hollander DA. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials. Clin Ophthalmol. 2014 Mar 27;8:643-52. doi: 10.2147/OPTH.S59197. eCollection 2014.
Results Reference
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Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

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