Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs

NCT00675207 | Completed Phase 4 DMC

• 1 other identifier: NWOIADJ 2006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.

Conditions

Primary Open Angle Glaucoma; Ocular Hypertension

Keywords

glaucoma; ocular hypertension; adjunctive treatment; prostaglandin; prostaglandin analog; brimonidine; dorzolamide; brinzolamide; alpha agonist; carbonic anhydrase inhibitor; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4

Study Arms (3)

1

ACTIVE COMPARATOR

Brimonidine purite 0.15%

Drug: Brimonidine purite 0.15%

2

ACTIVE COMPARATOR

Dorzolamide 2%

Drug: Dorzolamide 2%

3

ACTIVE COMPARATOR

Brinzolamide 1%

Drug: Brinzolamide 1%

Interventions

Brimonidine purite 0.15% DRUG

A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.

Also known as: Alphagan P 0.15%

1

Dorzolamide 2% DRUG

A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.

Also known as: Trusopt

2

Brinzolamide 1% DRUG

A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.

Also known as: Azopt

3

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary open-angle glaucoma or ocular hypertension.
• Must be over 40 years of age.
• Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).

You may not qualify if:

• History of angle closure or narrow angle.
• Previous intraocular surgery.
• Laser trabeculoplasty within 3 months prior to screening.
• History of uveitis or intraocular inflammation.
• Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
• Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
• Women of childbearing age who are pregnant or not using contraception.

Sponsors & Collaborators

• Northwestern Ophthalmic Institute S.C.: lead
• Research to Prevent Blindness: collaborator

Study Sites (1)

Northwestern Ophthalmic Institute S.C.

Glenview, Illinois, 60026, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

dorzolamide; brinzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Thomas E. Bournias, MD

  Northwestern Ophthalmic Institute S.C.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: January 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 8, 2008

Record last verified: 2008-05

Locations

US (1)