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

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Combigan Two Times Daily (BID)
Simbrinza Three Times Daily (TID)
Sponsored by
Cornerstone Health Care, PA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cornerstone Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combigan Two Times Daily (BID)

Simbrinza Three Times Daily (TID)

Arm Description

Combigan 0.2%/0.5% one drop Two Times Daily (BID)

Simbrinza 1/0.2% one drop Three Times Daily (TID)

Outcomes

Primary Outcome Measures

Intraocular Pressure
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

Ocular Symptom and Tolerability Questionaire
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.

Full Information

First Posted
June 12, 2014
Last Updated
October 23, 2018
Sponsor
Cornerstone Health Care, PA
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02167035
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cornerstone Health Care, PA
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combigan Two Times Daily (BID)
Arm Type
Active Comparator
Arm Description
Combigan 0.2%/0.5% one drop Two Times Daily (BID)
Arm Title
Simbrinza Three Times Daily (TID)
Arm Type
Active Comparator
Arm Description
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Intervention Type
Drug
Intervention Name(s)
Combigan Two Times Daily (BID)
Intervention Type
Drug
Intervention Name(s)
Simbrinza Three Times Daily (TID)
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
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.
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)
Secondary Outcome Measure Information:
Title
Ocular Symptom and Tolerability Questionaire
Description
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.
Time Frame
Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Tepedino, MD
Organizational Affiliation
Cornerstone Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornerstone Health Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

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

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