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

NCT00735449 | Completed Phase 4 Results

• 1 other identifier: GMA-COM-07-XTC
• Study Type: interventional
• Target: 204
• Locations: 2 countries
• Sites: 2

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.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Intraocular Pressure (IOP) at 10 AM at Week 12

  Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

  Week 12

Secondary Outcomes (4)

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

  Week 6

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

  Week 12

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

  Week 6

• Number of Subjects With Adverse Events

  Week 12

Study Arms (2)

Combigan ®

ACTIVE COMPARATOR

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

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

Timolol Maleate 0.5%

ACTIVE COMPARATOR

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

Drug: timolol maleate 0.5%; Drug: latanoprost 0.005%

Interventions

Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% DRUG

1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Also known as: Combigan®

Combigan ®

timolol maleate 0.5% DRUG

1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.

Also known as: Timpoptic®, Timoptol®

Timolol Maleate 0.5%

latanoprost 0.005% DRUG

1 drop of latanoprost 0.005% once nightly.

Also known as: Xalatan®

Combigan ®; Timolol Maleate 0.5%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Newark, New Jersey, United States

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 21792284 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination; Timolol; Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Brimonidine Tartrate; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Morpholines; Oxazines; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 23, 2019
• Results First Posted: November 24, 2011

Record last verified: 2019-04

Locations

US (1); CA (1)