Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/26/2018 |
| Start Date: | August 2014 |
| End Date: | March 2018 |
Pilot Study Comparison of Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in Subjects Currently Treated With Latanoprost For Open-Angle Glaucoma or Ocular Hypertension
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.
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.
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
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