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

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; Drug: timolol maleate 0.5%; Drug: latanoprost 0.005%

• Registration Number: NCT00735449
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-10-17
• Results First Submitted QC: 2011-10-17
• Results First Posted: 2011-11-24
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combigan ®	Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)
Combigan ®	latanoprost 0.005%	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)
Timolol Maleate 0.5%	timolol maleate 0.5%	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Timolol Maleate 0.5%	latanoprost 0.005%	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) at 10 AM at Week 12	Week 12	Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Secondary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) at 10 AM at Week 6	Week 6	Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Mean Intraocular Pressure (IOP) at 8 AM at Week 12	Week 12	Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.
Mean Intraocular Pressure (IOP) at 8 AM at Week 6	Week 6	Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Number of Subjects With Adverse Events	Week 12	Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).