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

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% (Drug); timolol maleate 0.5% (Drug); latanoprost 0.005% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: 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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Mean Intraocular Pressure (IOP) at 10 AM at Week 12

Secondary outcome:

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

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

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

Number of Subjects With Adverse Events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Newark, New Jersey, United States

Montreal, Quebec, Canada

Starting date: July 2008
Last updated: November 13, 2012