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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: latanoprost 0.005%; Drug: timolol maleate 0.5%; Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735449

GMA-COM-07-XTC

Details and patient eligibility

About

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

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Combigan ®

Active Comparator group

Description:

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

Treatment:

Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%

Drug: latanoprost 0.005%

Timolol Maleate 0.5%

Active Comparator group

Description:

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

Treatment:

Drug: timolol maleate 0.5%

Drug: latanoprost 0.005%