Overview

Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
Summary
To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability of each drug.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cornerstone Health Care, PA
Collaborator:
Allergan
Treatments:
Brimonidine Tartrate
Brimonidine Tartrate, Timolol Maleate Drug Combination
Brinzolamide
Criteria
Inclusion Criteria:

- Open-angle glaucoma or ocular Hypertension

- Currently treated with Latanoprost for min of 6 weeks

- Male or Female 18 yrs and older

- Best Corrected Visual Acuity 20/100 or better in both eyes

- Pachymetry >470 and < 640

- Women of childbearing potential must have a negative urine pregnancy test at the
screening/baseline visit

- Patient willing and capable of providing informed consent

Exclusion Criteria:

- C/D > 0.8

- Visual field loss, which in the opinion of the investigator is functionally
significant

- Current use of ocular steroids

- Concurrent significant active ocular disease History (within 3 months prior to
Screening) of ocular laser, intraocular, filtering or refractive surgery or planned
ocular surgery of any kind during study participation

- Change within prior 30 days or anticipated change in any systemic medication that is
known to affect IOP

- Uncontrolled systemic disease

- Significant ocular hyperemia at baseline

- Prior glaucoma procedure within 3 months

- Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing
potential and not using a reliable method of contraception

- Known allergy or sensitivity to any study medication

- Asthma or any other known medical condition that the investigator feels would put
patient at increased risk from any of the study medications

- Current enrollment in an investigational drug or device study or participation in such
a study within 30 days prior to Screening