Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

NCT01229462 | Completed Results

• 1 other identifier: 190342-035
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Conditions

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4

  Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

  Baseline, Week 4

Study Arms (2)

Combigan®

OTHER

One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution; Other: fixed combination vehicle

Alphagan® and Timolol Concurrent

ACTIVE COMPARATOR

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Drug: brimonidine tartrate ophthalmic solution; Drug: timolol ophthalmic solution

Interventions

brimonidine tartrate/timolol fixed combination ophthalmic solution DRUG

One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Also known as: Combigan®

Combigan®

brimonidine tartrate ophthalmic solution DRUG

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Also known as: Alphagan®

Alphagan® and Timolol Concurrent

timolol ophthalmic solution DRUG

One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Alphagan® and Timolol Concurrent

fixed combination vehicle OTHER

Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Combigan®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
• No anticipated wearing of contact lenses during study

You may not qualify if:

• Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
• Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
• Required regular use of other ocular medications except for occasional use of artificial tears

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Brimonidine Tartrate; Brimonidine Tartrate, Timolol Maleate Drug Combination

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Timolol; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 14, 2012
• Results First Posted: September 14, 2012

Record last verified: 2012-08

Locations

CN (1)