Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Completed · Phase 4
Conditions studied: Glaucoma, Ocular Hypertension
In brief
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.
Key facts
- Study ID
- NCT02167035
- Run by
- Cornerstone Health Care, PA
- People needed
- 43
- Starts
- 2014-08-01
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2018-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cornerstone Health Care — High Point, North Carolina, United States
Full record on ClinicalTrials.gov
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