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CompletedNCT00651612Updated Apr 3, 2008

Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

A Phase 3 interventional study of Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution and Concurrent brimonidine 0.2% and 0.5% timolol in Glaucoma and Ocular Hypertension, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-03.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
604
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

02

Conditions studied

  • Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 604 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of ocular hypertension or glaucoma
  • Patient requires IOP-lowering therapy in both eyes

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
604 participants (actual)

Study arms

  • Experimental
    1

    Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

    Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

  • Active comparator
    2

    Concurrent Brimonidine 0.2% and 0.5% Timolol

    Drug: Concurrent brimonidine 0.2% and 0.5% timolol

Interventions

  • DrugBrimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

    Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)

    Also known as: COMBIGAN™

  • DrugConcurrent brimonidine 0.2% and 0.5% timolol

    Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Time frame: Day 10

07

Study locations

1 site
  • Newport Beach, California, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00651612
Lead sponsor
Allergan
First posted
Apr 3, 2008
Start date
Nov 2005
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Apr 3, 2008

Study contacts

Medical Director
study director · Allergan
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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