NCT00348400

Brief Summary

Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

June 1, 2007

Status Verified

May 1, 2007

First QC Date

June 30, 2006

Last Update Submit

May 30, 2007

Conditions

Glaucoma

Interventions

Brimonidine Purite 0.15%, Dorzolamide 2%, LatanoprostDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · Male or female \> 18 years of age
  • Diagnosis of open-angle glaucoma or ocular hypertension
  • IOP \> 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
  • Presently on latanoprost monotherapy for at least 6 weeks
  • Ability to provide informed consent and likely to complete all study visits

You may not qualify if:

  • · Known contraindication or allergy to brimonidine or any of its components
  • Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
  • Uncontrolled systemic disease
  • Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
  • Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
  • Corneal abnormalities
  • History of intraocular surgery within the last 3 months
  • Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
  • Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Noecker

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Brimonidine TartratedorzolamideLatanoprost

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Robert Noecker, MD

    UPMC Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Last Updated

June 1, 2007

Record last verified: 2007-05

Locations

US(1)