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Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Primary Purpose

Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%

timolol maleate 0.5%

latanoprost 0.005%

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:

Be at least 18 years of age
Give written informed consent
Be in good general health as determined by your doctor
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills)
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits

Exclusion Criteria:

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
History of severe renal or hepatic impairment
Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Combigan ®

Timolol Maleate 0.5%

Arm Description

Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)

Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure (IOP) at 10 AM at Week 12

Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Secondary Outcome Measures

Mean Intraocular Pressure (IOP) at 10 AM at Week 6

Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

Mean Intraocular Pressure (IOP) at 8 AM at Week 12

Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.

Mean Intraocular Pressure (IOP) at 8 AM at Week 6

Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

Number of Subjects With Adverse Events

Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).

Full Information

NCT ID

NCT00735449

First Posted

August 13, 2008

Last Updated

April 10, 2019

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00735449

Brief Title

Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Official Title

Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

5. Study Description

Brief Summary

Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

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

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combigan ®

Arm Type

Active Comparator

Arm Description

Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)

Arm Title

Timolol Maleate 0.5%

Arm Type

Active Comparator

Arm Description

Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)

Intervention Type

Drug

Intervention Name(s)

Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%

Other Intervention Name(s)

Combigan®

Intervention Description

1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Intervention Type

Drug

Intervention Name(s)

timolol maleate 0.5%

Other Intervention Name(s)

Timpoptic®, Timoptol®

Intervention Description

1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Intervention Type

Drug

Intervention Name(s)

latanoprost 0.005%

Other Intervention Name(s)

Xalatan®

Intervention Description

1 drop of latanoprost 0.005% once nightly.

Primary Outcome Measure Information:

Title

Mean Intraocular Pressure (IOP) at 10 AM at Week 12

Description

Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Mean Intraocular Pressure (IOP) at 10 AM at Week 6

Description

Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

Time Frame

Week 6

Title

Mean Intraocular Pressure (IOP) at 8 AM at Week 12

Description

Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.

Time Frame

Week 12

Title

Mean Intraocular Pressure (IOP) at 8 AM at Week 6

Description

Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

Time Frame

Week 6

Title

Number of Subjects With Adverse Events

Description

Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be at least 18 years of age Give written informed consent Be in good general health as determined by your doctor Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills) Understand the study instructions, and be able to follow the study instructions; and Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits Exclusion Criteria: Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation History of severe renal or hepatic impairment Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

City

Newark

State/Province

New Jersey

Country

United States

City

Montreal

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21792284

Citation

Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA. Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost. Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8.

Results Reference

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Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

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