Trial Outcomes & Findings for Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID) (NCT NCT02167035)
NCT ID: NCT02167035
Last Updated: 2018-10-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)
Results posted on
2018-10-24
Participant Flow
Participant milestones
| Measure |
Combigan Two Times Daily (BID)
Combigan 0.2%/0.5% one drop Two Times Daily (BID)
Combigan Two Times Daily (BID)
|
Simbrinza Three Times Daily (TID)
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Simbrinza Three Times Daily (TID)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Combigan Two Times Daily (BID)
Combigan 0.2%/0.5% one drop Two Times Daily (BID)
Combigan Two Times Daily (BID)
|
Simbrinza Three Times Daily (TID)
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Simbrinza Three Times Daily (TID)
|
|---|---|---|
|
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
Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Baseline characteristics by cohort
| Measure |
Combigan Twice Daily (BID)
n=21 Participants
Combigan 0.2%/0.5% one drop Twice Daily (BID)
Combigan Twice Daily (BID)
|
Simbrinza Three Times Daily (TID)
n=22 Participants
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Simbrinza Three Times Daily (TID)
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Combigan BID
n=17 Participants
Combigan 0.2%/0.5% one drop Twice Daily (BID)
Combigan Twice Daily (BID)
|
Simbrinza TID
n=19 Participants
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Simbrinza Three Times Daily (TID)
|
|---|---|---|
|
Intraocular Pressure
Baseline 8am IOP
|
19.7 mmHg
Standard Deviation 5.33
|
18.1 mmHg
Standard Deviation 3.31
|
|
Intraocular Pressure
Baseline 10am IOP
|
19.1 mmHg
Standard Deviation 4.42
|
18.8 mmHg
Standard Deviation 4.26
|
|
Intraocular Pressure
Baseline 4pm IOP
|
17.6 mmHg
Standard Deviation 4.24
|
17.6 mmHg
Standard Deviation 3.83
|
|
Intraocular Pressure
Baseline Diurnal IOP
|
18.8 mmHg
Standard Deviation 4.42
|
18.1 mmHg
Standard Deviation 3.53
|
|
Intraocular Pressure
Visit 3 8am IOP
|
17.6 mmHg
Standard Deviation 4.47
|
17.4 mmHg
Standard Deviation 2.26
|
|
Intraocular Pressure
Visit 3 10am IOP
|
17.6 mmHg
Standard Deviation 3.08
|
16.2 mmHg
Standard Deviation 2.52
|
|
Intraocular Pressure
Visit 3 4pm IOP
|
17.1 mmHg
Standard Deviation 3.36
|
17.6 mmHg
Standard Deviation 4.04
|
|
Intraocular Pressure
Visit 3 Diurnal IOP
|
17.4 mmHg
Standard Deviation 3.12
|
17.0 mmHg
Standard Deviation 2.51
|
|
Intraocular Pressure
Visit 4 8am IOP
|
18.7 mmHg
Standard Deviation 4.19
|
18.4 mmHg
Standard Deviation 3.44
|
|
Intraocular Pressure
Visit 4 10am IOP
|
17.7 mmHg
Standard Deviation 3.33
|
18.1 mmHg
Standard Deviation 3.96
|
|
Intraocular Pressure
Visit 4 4pm IOP
|
18.1 mmHg
Standard Deviation 3.22
|
17.6 mmHg
Standard Deviation 3.43
|
|
Intraocular Pressure
Visit 4 Diurnal IOP
|
18.1 mmHg
Standard Deviation 2.66
|
18.0 mmHg
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Combigan BID
n=17 Participants
Combigan 0.2%/0.5% one drop Twice Daily (BID)
Combigan Twice Daily (BID)
|
Simbrinza TID
n=19 Participants
Simbrinza 1/0.2% one drop Three Times Daily (TID)
Simbrinza Three Times Daily (TID)
|
|---|---|---|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Burning/Stinging Upon Instillation
|
0.1 units on a scale
Standard Deviation 0.33
|
0.1 units on a scale
Standard Deviation 0.32
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - non-instillation Burning/stinging
|
0.1 units on a scale
Standard Deviation 0.24
|
0.1 units on a scale
Standard Deviation 0.32
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Dry/Gritty Eye
|
0.3 units on a scale
Standard Deviation 0.47
|
0.4 units on a scale
Standard Deviation 0.60
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Foreign Body Sensation
|
0.1 units on a scale
Standard Deviation 0.24
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Eye Redness
|
0.1 units on a scale
Standard Deviation 0.33
|
0.2 units on a scale
Standard Deviation 0.63
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Blurred Vision
|
0.1 units on a scale
Standard Deviation 0.33
|
0.3 units on a scale
Standard Deviation 0.56
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Dry Mouth
|
0.2 units on a scale
Standard Deviation 0.53
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Bad Taste/change of taste
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Headache
|
0.1 units on a scale
Standard Deviation 0.24
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Ocular Symptom and Tolerability Questionaire
Baseline - Fatigue Malaise
|
0.2 units on a scale
Standard Deviation 0.44
|
0.1 units on a scale
Standard Deviation 0.32
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Burning/Stinging Upon Instillation
|
0.02 units on a scale
Standard Deviation 0.39
|
0.2 units on a scale
Standard Deviation 0.42
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Non-Instillation Burning/Stinging
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.32
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Dry/Gritty Eye
|
0.1 units on a scale
Standard Deviation 0.33
|
0.2 units on a scale
Standard Deviation 0.37
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Foreign Body Sensation
|
0.1 units on a scale
Standard Deviation 0.49
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Eye Redness
|
0.1 units on a scale
Standard Deviation 0.24
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Blurred Vision
|
0.0 units on a scale
Standard Deviation 0.0
|
0.2 units on a scale
Standard Deviation 0.37
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Dry Mouth
|
0.2 units on a scale
Standard Deviation 0.53
|
0.3 units on a scale
Standard Deviation 0.67
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Bad Taste/Change of Taste
|
0.0 units on a scale
Standard Deviation 0.0
|
0.3 units on a scale
Standard Deviation 0.65
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Headache
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Ocular Symptom and Tolerability Questionaire
Visit 2- Fatique Malaise
|
0.1 units on a scale
Standard Deviation 0.33
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Burning/Stinging Upon Instillation
|
0.4 units on a scale
Standard Deviation 0.49
|
0.3 units on a scale
Standard Deviation 0.58
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Non-Instillation Burning/Stinging
|
0.1 units on a scale
Standard Deviation 0.24
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Dry/Gritty Eye
|
0.2 units on a scale
Standard Deviation 0.56
|
0.3 units on a scale
Standard Deviation 0.67
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Foreign Body Sensation
|
0.1 units on a scale
Standard Deviation 0.24
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Eye Redness
|
0.1 units on a scale
Standard Deviation 0.24
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Blurred Vision
|
0.0 units on a scale
Standard Deviation 0.0
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Dry Mouth
|
0.2 units on a scale
Standard Deviation 0.44
|
0.6 units on a scale
Standard Deviation 0.96
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Bad Taste/Change of Taste
|
0.0 units on a scale
Standard Deviation 0.0
|
0.4 units on a scale
Standard Deviation 0.68
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Headache
|
0.1 units on a scale
Standard Deviation 0.24
|
0.0 units on a scale
Standard Deviation 0.0
|
|
Ocular Symptom and Tolerability Questionaire
Visit 3- Fatigue Malaise
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.23
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Burning/Stinging Upon Instillation
|
0.4 units on a scale
Standard Deviation 0.50
|
0.6 units on a scale
Standard Deviation 0.80
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Non-Instillation Burning/Stinging
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.24
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Dry/Gritty Eye
|
0.2 units on a scale
Standard Deviation 0.40
|
0.4 units on a scale
Standard Deviation 0.61
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Foreign Body Sensation
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.33
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Eye Redness
|
0.2 units on a scale
Standard Deviation 0.40
|
0.2 units on a scale
Standard Deviation 0.73
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Blurred Vision
|
0.1 units on a scale
Standard Deviation 0.25
|
0.1 units on a scale
Standard Deviation 0.24
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Dry Mouth
|
0.4 units on a scale
Standard Deviation 0.73
|
0.4 units on a scale
Standard Deviation 0.71
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Bad Taste/Change of Taste
|
0.0 units on a scale
Standard Deviation 0.0
|
0.3 units on a scale
Standard Deviation 0.47
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Headache
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.33
|
|
Ocular Symptom and Tolerability Questionaire
Visit 4- Fatigue Malaise
|
0.0 units on a scale
Standard Deviation 0.0
|
0.1 units on a scale
Standard Deviation 0.24
|
Adverse Events
Combigan BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Simbrinza TID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combigan BID
n=21 participants at risk
Combigan 0.2%/0.5% one drop BID
Combigan BID
|
Simbrinza TID
n=22 participants at risk
Simbrinza 1/0.2% one drop TID
Simbrinza TID
|
|---|---|---|
|
Eye disorders
Ocular Adverse Events
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.
Site utilized a systematic assessment of adverse events on this trial. Adverse events (AEs) were assessed at each study visit outlined on the protocol. Subjects were instructed to contact site to report any AEs between study visits. Unscheduled visits were conducted to assess these reported AEs between study visits.
|
9.1%
2/22 • Number of events 2 • Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.
Site utilized a systematic assessment of adverse events on this trial. Adverse events (AEs) were assessed at each study visit outlined on the protocol. Subjects were instructed to contact site to report any AEs between study visits. Unscheduled visits were conducted to assess these reported AEs between study visits.
|
|
General disorders
Non-ocular Adverse Events
|
9.5%
2/21 • Number of events 5 • Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.
Site utilized a systematic assessment of adverse events on this trial. Adverse events (AEs) were assessed at each study visit outlined on the protocol. Subjects were instructed to contact site to report any AEs between study visits. Unscheduled visits were conducted to assess these reported AEs between study visits.
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.
Site utilized a systematic assessment of adverse events on this trial. Adverse events (AEs) were assessed at each study visit outlined on the protocol. Subjects were instructed to contact site to report any AEs between study visits. Unscheduled visits were conducted to assess these reported AEs between study visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor may request but cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER