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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167035
Recruitment Status : Completed
First Posted : June 18, 2014
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Michael Tepedino MD, Cornerstone Health Care, PA

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE June 18, 2014
Results First Submitted Date  ICMJE March 29, 2018
Results First Posted Date  ICMJE October 24, 2018
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
Intraocular Pressure [ Time Frame: Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00) ]
The Intraocular Pressure will be assessed on study subjects. IOP (Intraocular Pressure) will be measured using a Goldmann applanation tonometer. Both eyes will be tested, with the right eye preceding the left eye. The operator will initially set the dial at 10 mmHg, then look through the slit lamp and adjust the dial to take the reading, and then record the results. The procedure will be repeated on the same eye twice consecutively. If the measurements are within 2mmHg or less of each other, the mean of the 2 reading will be reported as the IOP at that time point. If the 2 reading are more than 2mmHg apart from each other, a third (consecutive) reading will be taken and the median (middle) IOP will be reported as the IOP at that time point. Preferable, the same operator will measure IOP and the same tonometer will be used at each visit.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
Intra Ocular Pressure [ Time Frame: Day 90 ]
The Intra Ocular Pressure will be assessed on study subjects.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
Ocular Symptom and Tolerability Questionaire [ Time Frame: Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90) ]
The secondary endpoint of this study was to determine the tolerability of each treatment group by utilizing ocular symptom questionnaires administered at each study visit. These questionnaires assessed Oral effects (bad taste, dry mouth) and Ocular comfort effects (itching, burning, stinging, burning on instillation, blurred vision). The scale proved was none=0, mild=1, moderate=2, severe=3.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
Tolerability [ Time Frame: Day 90 ]
A questionnaire will be used to determine how subject tolerated study drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Combigan Two Times Daily (BID)
  • Drug: Simbrinza Three Times Daily (TID)
Study Arms  ICMJE
  • Active Comparator: Combigan Two Times Daily (BID)
    Combigan 0.2%/0.5% one drop Two Times Daily (BID)
    Intervention: Drug: Combigan Two Times Daily (BID)
  • Active Comparator: Simbrinza Three Times Daily (TID)
    Simbrinza 1/0.2% one drop Three Times Daily (TID)
    Intervention: Drug: Simbrinza Three Times Daily (TID)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2017)
43
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
40
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02167035
Other Study ID Numbers  ICMJE TEP001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Tepedino MD, Cornerstone Health Care, PA
Study Sponsor  ICMJE Cornerstone Health Care, PA
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Michael E Tepedino, MD Cornerstone Health Care
PRS Account Cornerstone Health Care, PA
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP