Glaucoma, Ocular Hypertension
Conditions
Keywords
Open-Angle Glaucoma, 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.
Interventions
DRUGCombigan Two Times Daily (BID)
DRUGSimbrinza Three Times Daily (TID)
Sponsors
Allergan
Cornerstone Health Care, PA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | 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
| Measure | Time frame | Description |
|---|---|---|
| Ocular Symptom and Tolerability Questionaire | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combigan Twice Daily (BID) Combigan 0.2%/0.5% one drop Twice Daily (BID)
Combigan Twice Daily (BID) | 21 |
| Simbrinza Three Times Daily (TID) Simbrinza 1/0.2% one drop Three Times Daily (TID)
Simbrinza Three Times Daily (TID) | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Randomized to incorrect Study Medication | 0 | 1 |
Baseline characteristics
| Characteristic | Combigan Twice Daily (BID) | Simbrinza Three Times Daily (TID) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Continuous | 67.9 years STANDARD_DEVIATION 11.43 | 67.7 years STANDARD_DEVIATION 8.43 | 67.8 years STANDARD_DEVIATION 9.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 3 / 21 | 3 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
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.
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)
Population: Primary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combigan BID | Intraocular Pressure | Baseline 8am IOP | 19.7 mmHg | Standard Deviation 5.33 |
| Combigan BID | Intraocular Pressure | Baseline 10am IOP | 19.1 mmHg | Standard Deviation 4.42 |
| Combigan BID | Intraocular Pressure | Baseline 4pm IOP | 17.6 mmHg | Standard Deviation 4.24 |
| Combigan BID | Intraocular Pressure | Baseline Diurnal IOP | 18.8 mmHg | Standard Deviation 4.42 |
| Combigan BID | Intraocular Pressure | Visit 3 8am IOP | 17.6 mmHg | Standard Deviation 4.47 |
| Combigan BID | Intraocular Pressure | Visit 3 10am IOP | 17.6 mmHg | Standard Deviation 3.08 |
| Combigan BID | Intraocular Pressure | Visit 3 4pm IOP | 17.1 mmHg | Standard Deviation 3.36 |
| Combigan BID | Intraocular Pressure | Visit 3 Diurnal IOP | 17.4 mmHg | Standard Deviation 3.12 |
| Combigan BID | Intraocular Pressure | Visit 4 8am IOP | 18.7 mmHg | Standard Deviation 4.19 |
| Combigan BID | Intraocular Pressure | Visit 4 10am IOP | 17.7 mmHg | Standard Deviation 3.33 |
| Combigan BID | Intraocular Pressure | Visit 4 4pm IOP | 18.1 mmHg | Standard Deviation 3.22 |
| Combigan BID | Intraocular Pressure | Visit 4 Diurnal IOP | 18.1 mmHg | Standard Deviation 2.66 |
| Simbrinza TID | Intraocular Pressure | Visit 4 4pm IOP | 17.6 mmHg | Standard Deviation 3.43 |
| Simbrinza TID | Intraocular Pressure | Baseline 8am IOP | 18.1 mmHg | Standard Deviation 3.31 |
| Simbrinza TID | Intraocular Pressure | Visit 3 4pm IOP | 17.6 mmHg | Standard Deviation 4.04 |
| Simbrinza TID | Intraocular Pressure | Baseline 10am IOP | 18.8 mmHg | Standard Deviation 4.26 |
| Simbrinza TID | Intraocular Pressure | Visit 4 10am IOP | 18.1 mmHg | Standard Deviation 3.96 |
| Simbrinza TID | Intraocular Pressure | Baseline 4pm IOP | 17.6 mmHg | Standard Deviation 3.83 |
| Simbrinza TID | Intraocular Pressure | Visit 3 Diurnal IOP | 17.0 mmHg | Standard Deviation 2.51 |
| Simbrinza TID | Intraocular Pressure | Baseline Diurnal IOP | 18.1 mmHg | Standard Deviation 3.53 |
| Simbrinza TID | Intraocular Pressure | Visit 4 Diurnal IOP | 18.0 mmHg | Standard Deviation 3.32 |
| Simbrinza TID | Intraocular Pressure | Visit 3 8am IOP | 17.4 mmHg | Standard Deviation 2.26 |
| Simbrinza TID | Intraocular Pressure | Visit 4 8am IOP | 18.4 mmHg | Standard Deviation 3.44 |
| Simbrinza TID | Intraocular Pressure | Visit 3 10am IOP | 16.2 mmHg | Standard Deviation 2.52 |
Secondary
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.
Time frame: Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)
Population: Secondary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Burning/Stinging Upon Instillation | 0.4 units on a scale | Standard Deviation 0.49 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Dry/Gritty Eye | 0.3 units on a scale | Standard Deviation 0.47 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Non-Instillation Burning/Stinging | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Burning/Stinging Upon Instillation | 0.02 units on a scale | Standard Deviation 0.39 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Dry/Gritty Eye | 0.2 units on a scale | Standard Deviation 0.56 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Blurred Vision | 0.1 units on a scale | Standard Deviation 0.33 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Foreign Body Sensation | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Non-Instillation Burning/Stinging | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Eye Redness | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Dry/Gritty Eye | 0.1 units on a scale | Standard Deviation 0.33 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Blurred Vision | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - non-instillation Burning/stinging | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Dry Mouth | 0.2 units on a scale | Standard Deviation 0.44 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Foreign Body Sensation | 0.1 units on a scale | Standard Deviation 0.49 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Bad Taste/Change of Taste | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Dry Mouth | 0.2 units on a scale | Standard Deviation 0.53 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Headache | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Eye Redness | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 3- Fatigue Malaise | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Foreign Body Sensation | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Burning/Stinging Upon Instillation | 0.4 units on a scale | Standard Deviation 0.5 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Blurred Vision | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Non-Instillation Burning/Stinging | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Bad Taste/change of taste | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Dry/Gritty Eye | 0.2 units on a scale | Standard Deviation 0.4 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Dry Mouth | 0.2 units on a scale | Standard Deviation 0.53 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Foreign Body Sensation | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Burning/Stinging Upon Instillation | 0.1 units on a scale | Standard Deviation 0.33 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Eye Redness | 0.2 units on a scale | Standard Deviation 0.4 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Bad Taste/Change of Taste | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Blurred Vision | 0.1 units on a scale | Standard Deviation 0.25 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Headache | 0.1 units on a scale | Standard Deviation 0.24 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Dry Mouth | 0.4 units on a scale | Standard Deviation 0.73 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Headache | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Bad Taste/Change of Taste | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Eye Redness | 0.1 units on a scale | Standard Deviation 0.33 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Headache | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 2- Fatique Malaise | 0.1 units on a scale | Standard Deviation 0.33 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Visit 4- Fatigue Malaise | 0.0 units on a scale | Standard Deviation 0 |
| Combigan BID | Ocular Symptom and Tolerability Questionaire | Baseline - Fatigue Malaise | 0.2 units on a scale | Standard Deviation 0.44 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Fatigue Malaise | 0.1 units on a scale | Standard Deviation 0.24 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Burning/Stinging Upon Instillation | 0.1 units on a scale | Standard Deviation 0.32 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - non-instillation Burning/stinging | 0.1 units on a scale | Standard Deviation 0.32 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Dry/Gritty Eye | 0.4 units on a scale | Standard Deviation 0.6 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Foreign Body Sensation | 0.1 units on a scale | Standard Deviation 0.23 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Eye Redness | 0.2 units on a scale | Standard Deviation 0.63 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Blurred Vision | 0.3 units on a scale | Standard Deviation 0.56 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Dry Mouth | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Bad Taste/change of taste | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Headache | 0.1 units on a scale | Standard Deviation 0.23 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Baseline - Fatigue Malaise | 0.1 units on a scale | Standard Deviation 0.32 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Burning/Stinging Upon Instillation | 0.2 units on a scale | Standard Deviation 0.42 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Dry/Gritty Eye | 0.2 units on a scale | Standard Deviation 0.37 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Foreign Body Sensation | 0.1 units on a scale | Standard Deviation 0.23 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Eye Redness | 0.1 units on a scale | Standard Deviation 0.23 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Blurred Vision | 0.2 units on a scale | Standard Deviation 0.37 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Dry Mouth | 0.3 units on a scale | Standard Deviation 0.67 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Bad Taste/Change of Taste | 0.3 units on a scale | Standard Deviation 0.65 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Headache | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Fatique Malaise | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Burning/Stinging Upon Instillation | 0.3 units on a scale | Standard Deviation 0.58 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Non-Instillation Burning/Stinging | 0.1 units on a scale | Standard Deviation 0.23 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Dry/Gritty Eye | 0.3 units on a scale | Standard Deviation 0.67 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Foreign Body Sensation | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Eye Redness | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Blurred Vision | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Dry Mouth | 0.6 units on a scale | Standard Deviation 0.96 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Bad Taste/Change of Taste | 0.4 units on a scale | Standard Deviation 0.68 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Headache | 0.0 units on a scale | Standard Deviation 0 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 3- Fatigue Malaise | 0.1 units on a scale | Standard Deviation 0.23 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Burning/Stinging Upon Instillation | 0.6 units on a scale | Standard Deviation 0.8 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Non-Instillation Burning/Stinging | 0.1 units on a scale | Standard Deviation 0.24 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Dry/Gritty Eye | 0.4 units on a scale | Standard Deviation 0.61 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Foreign Body Sensation | 0.1 units on a scale | Standard Deviation 0.33 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Eye Redness | 0.2 units on a scale | Standard Deviation 0.73 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Blurred Vision | 0.1 units on a scale | Standard Deviation 0.24 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Dry Mouth | 0.4 units on a scale | Standard Deviation 0.71 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Bad Taste/Change of Taste | 0.3 units on a scale | Standard Deviation 0.47 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 4- Headache | 0.1 units on a scale | Standard Deviation 0.33 |
| Simbrinza TID | Ocular Symptom and Tolerability Questionaire | Visit 2- Non-Instillation Burning/Stinging | 0.1 units on a scale | Standard Deviation 0.32 |