CompletedNCT00652483Updated Apr 3, 2008

Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

A Phase 3 interventional study of Brimonidine ophthalmic solution 0.1% and Brimonidine ophthalmic solution 0.2% 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: 433
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Conditions studied

Glaucoma
Ocular Hypertension

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In context

Glaucoma

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

This study's enrollment of 433 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

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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.

Who can participate

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

Inclusion criteria

Ocular hypertension or glaucoma in both eyes

Exclusion criteria

Exclusion Criteria:

Uncontrolled systemic disease
Known allergy or sensitivity to brimonidine

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 433 participants (actual)

Study arms

Experimental
1
Brimonidine ophthalmic solution 0.1%
Drug: Brimonidine ophthalmic solution 0.1%
Active comparator
2
Brimonidine ophthalmic solution 0.2%
Drug: Brimonidine ophthalmic solution 0.2%

Interventions

DrugBrimonidine ophthalmic solution 0.1%
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
DrugBrimonidine ophthalmic solution 0.2%
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Also known as: ALPHAGAN®

What researchers measure

Primary outcomes

Intraocular pressure (IOP)
Time frame: Week 2 - Month 3

Secondary outcomes

IOP
Time frame: Month 6 - Month 12

Study locations

1 site

Atlanta, Georgia, United States

References and documents

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 ↗

Registry details

Key details

Study ID: NCT00652483
Lead sponsor: Allergan
First posted: Apr 3, 2008
Start date: May 2003
Primary completion: Dec 2003
Completion: Sep 2004
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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