Clinical trial NCT00735449: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Mean Intraocular Pressure (IOP) at 10 AM at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Mean Intraocular Pressure (IOP) at 10 AM at Week 6
timeFrame: Week 6
measure: Mean Intraocular Pressure (IOP) at 8 AM at Week 12
timeFrame: Week 12
measure: Mean Intraocular Pressure (IOP) at 8 AM at Week 6
timeFrame: Week 6
measure: Number of Subjects With Adverse Events
timeFrame: Week 12
Other outcomes:
Locations:
city: Newark
country: United States
state: New Jersey
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
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.