Status:
COMPLETED
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
Lead Sponsor:
Allergan
Conditions:
Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00735449
Start Date
July 1 2008
End Date
December 1 2009
Last Update
April 23 2019
Active Locations (2)
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1
Newark, New Jersey, United States
2
Montreal, Quebec, Canada