Clinical trial NCT02167035: Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Cornerstone Health Care, PA
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2014-06-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Intraocular Pressure
timeFrame: Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)
Secondary outcomes:
measure: Ocular Symptom and Tolerability Questionaire
timeFrame: Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)
Other outcomes:
Locations:
city: High Point
country: United States
facility: Cornerstone Health Care
state: North Carolina
Study officials:
affiliation: Cornerstone Health Care
name: Michael E Tepedino, MD
role: PRINCIPAL_INVESTIGATOR
References: