- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735449
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
April 10, 2019 updated by: Allergan
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Montreal, Quebec, Canada
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New Jersey
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Newark, New Jersey, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Combigan ®
Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)
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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.
Other Names:
1 drop of latanoprost 0.005% once nightly.
Other Names:
|
Active Comparator: Timolol Maleate 0.5%
Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
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1 drop of latanoprost 0.005% once nightly.
Other Names:
1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Intraocular Pressure (IOP) at 10 AM at Week 12
Time Frame: Week 12
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Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.
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Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Intraocular Pressure (IOP) at 10 AM at Week 6
Time Frame: Week 6
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Mean IOP at 10 AM at week 6.
IOP is a measurement of the fluid pressure inside the eye.
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Week 6
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Mean Intraocular Pressure (IOP) at 8 AM at Week 12
Time Frame: Week 12
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Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.
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Week 12
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Mean Intraocular Pressure (IOP) at 8 AM at Week 6
Time Frame: Week 6
|
Mean IOP at 8 AM at week 6.
IOP is a measurement of the fluid pressure inside the eye.
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Week 6
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Number of Subjects With Adverse Events
Time Frame: Week 12
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Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).
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Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
August 13, 2008
First Submitted That Met QC Criteria
August 14, 2008
First Posted (Estimate)
August 15, 2008
Study Record Updates
Last Update Posted (Actual)
April 23, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Pharmaceutical Solutions
- Ophthalmic Solutions
- Timolol
- Brimonidine Tartrate
- Maleic acid
- Latanoprost
Other Study ID Numbers
- GMA-COM-07-XTC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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