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

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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

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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Combigan Two Times Daily (BID) Drug: Simbrinza Three Times Daily (TID) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Combigan Two Times Daily (BID)
Combigan 0.2%/0.5% one drop Two Times Daily (BID)
Drug: Combigan Two Times Daily (BID)
Active Comparator: Simbrinza Three Times Daily (TID)
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Drug: Simbrinza Three Times Daily (TID)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167035


Locations
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United States, North Carolina
Cornerstone Health Care
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Cornerstone Health Care, PA
Allergan
Investigators
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Principal Investigator: Michael E Tepedino, MD Cornerstone Health Care
  Study Documents (Full-Text)

Documents provided by Michael Tepedino MD, Cornerstone Health Care, PA:
Study Protocol  [PDF] May 11, 2016
Statistical Analysis Plan  [PDF] May 10, 2018


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Responsible Party: Michael Tepedino MD, Director of Clinical Research, Cornerstone Health Care, PA
ClinicalTrials.gov Identifier: NCT02167035     History of Changes
Other Study ID Numbers: TEP001
First Posted: June 18, 2014    Key Record Dates
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018
Last Verified: October 2018

Keywords provided by Michael Tepedino MD, Cornerstone Health Care, PA:
Open-Angle Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brimonidine Tartrate, Timolol Maleate Drug Combination
Brimonidine Tartrate
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors