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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Combigan Two Times Daily (BID)
* Drug: Simbrinza Three Times Daily (TID)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combigan Two Times Daily (BID)<br>Combigan 0.2%/0.5% one drop Two Times Daily (BID) | Drug: Combigan Two Times Daily (BID)<br> <br> |
| Active Comparator: Simbrinza Three Times Daily (TID)<br>Simbrinza 1/0.2% one drop Three Times Daily (TID) | Drug: Simbrinza Three Times Daily (TID)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-Angle Glaucoma, Ocular Hypertension