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