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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Glaucoma
Ocular Hypertension
Interventions Drug: Combigan Two Times Daily (BID)
Drug: Simbrinza Three Times Daily (TID)
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combigan Two Times Daily (BID) Simbrinza Three Times Daily (TID)
Hide Arm/Group Description

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

Combigan Two Times Daily (BID)

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

Simbrinza Three Times Daily (TID)

Period Title: Overall Study
Started 21 22
Completed 16 16
Not Completed 5 6
Reason Not Completed
Adverse Event             2             2
Lost to Follow-up             3             3
Randomized to incorrect Study Medication             0             1
Arm/Group Title Combigan Twice Daily (BID) Simbrinza Three Times Daily (TID) Total
Hide Arm/Group Description

Combigan 0.2%/0.5% one drop Twice Daily (BID)

Combigan Twice Daily (BID)

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

Simbrinza Three Times Daily (TID)

Total of all reporting groups
Overall Number of Baseline Participants 21 22 43
Hide Baseline Analysis Population Description
Analysis was conducted on the Safety Population (N=43) for Subject Demographics.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  19.0%
5
  22.7%
9
  20.9%
>=65 years
17
  81.0%
17
  77.3%
34
  79.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 43 participants
67.9  (11.43) 67.7  (8.43) 67.8  (9.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
Female
16
  76.2%
13
  59.1%
29
  67.4%
Male
5
  23.8%
9
  40.9%
14
  32.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  28.6%
7
  31.8%
13
  30.2%
White
15
  71.4%
15
  68.2%
30
  69.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 22 participants 43 participants
21
 100.0%
22
 100.0%
43
 100.0%
1.Primary Outcome
Title Intraocular Pressure
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Combigan BID Simbrinza TID
Hide Arm/Group Description:

Combigan 0.2%/0.5% one drop Twice Daily (BID)

Combigan Twice Daily (BID)

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

Simbrinza Three Times Daily (TID)

Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 8am IOP 19.7  (5.33) 18.1  (3.31)
Baseline 10am IOP 19.1  (4.42) 18.8  (4.26)
Baseline 4pm IOP 17.6  (4.24) 17.6  (3.83)
Baseline Diurnal IOP 18.8  (4.42) 18.1  (3.53)
Visit 3 8am IOP 17.6  (4.47) 17.4  (2.26)
Visit 3 10am IOP 17.6  (3.08) 16.2  (2.52)
Visit 3 4pm IOP 17.1  (3.36) 17.6  (4.04)
Visit 3 Diurnal IOP 17.4  (3.12) 17.0  (2.51)
Visit 4 8am IOP 18.7  (4.19) 18.4  (3.44)
Visit 4 10am IOP 17.7  (3.33) 18.1  (3.96)
Visit 4 4pm IOP 18.1  (3.22) 17.6  (3.43)
Visit 4 Diurnal IOP 18.1  (2.66) 18.0  (3.32)
2.Secondary Outcome
Title Ocular Symptom and Tolerability Questionaire
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Combigan BID Simbrinza TID
Hide Arm/Group Description:

Combigan 0.2%/0.5% one drop BID

Combigan BID

Simbrinza 1/0.2% one drop TID

Simbrinza TID

Overall Number of Participants Analyzed 17 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline - Burning/Stinging Upon Instillation 0.1  (0.33) 0.1  (0.32)
Baseline - non-instillation Burning/stinging 0.1  (0.24) 0.1  (0.32)
Baseline - Dry/Gritty Eye 0.3  (0.47) 0.4  (0.60)
Baseline - Foreign Body Sensation 0.1  (0.24) 0.1  (0.23)
Baseline - Eye Redness 0.1  (0.33) 0.2  (0.63)
Baseline - Blurred Vision 0.1  (0.33) 0.3  (0.56)
Baseline - Dry Mouth 0.2  (0.53) 0.0  (0.00)
Baseline - Bad Taste/change of taste 0.0  (0.00) 0.0  (0.00)
Baseline - Headache 0.1  (0.24) 0.1  (0.23)
Baseline - Fatigue Malaise 0.2  (0.44) 0.1  (0.32)
Visit 2- Burning/Stinging Upon Instillation 0.02  (0.39) 0.2  (0.42)
Visit 2- Non-Instillation Burning/Stinging 0.0  (0.0) 0.1  (0.32)
Visit 2- Dry/Gritty Eye 0.1  (0.33) 0.2  (0.37)
Visit 2- Foreign Body Sensation 0.1  (0.49) 0.1  (0.23)
Visit 2- Eye Redness 0.1  (0.24) 0.1  (0.23)
Visit 2- Blurred Vision 0.0  (0.0) 0.2  (0.37)
Visit 2- Dry Mouth 0.2  (0.53) 0.3  (0.67)
Visit 2- Bad Taste/Change of Taste 0.0  (0.0) 0.3  (0.65)
Visit 2- Headache 0.0  (0.0) 0.0  (0.0)
Visit 2- Fatique Malaise 0.1  (0.33) 0.0  (0.0)
Visit 3- Burning/Stinging Upon Instillation 0.4  (0.49) 0.3  (0.58)
Visit 3- Non-Instillation Burning/Stinging 0.1  (0.24) 0.1  (0.23)
Visit 3- Dry/Gritty Eye 0.2  (0.56) 0.3  (0.67)
Visit 3- Foreign Body Sensation 0.1  (0.24) 0.0  (0.0)
Visit 3- Eye Redness 0.1  (0.24) 0.0  (0.0)
Visit 3- Blurred Vision 0.0  (0.0) 0.0  (0.0)
Visit 3- Dry Mouth 0.2  (0.44) 0.6  (0.96)
Visit 3- Bad Taste/Change of Taste 0.0  (0.0) 0.4  (0.68)
Visit 3- Headache 0.1  (0.24) 0.0  (0.0)
Visit 3- Fatigue Malaise 0.0  (0.0) 0.1  (0.23)
Visit 4- Burning/Stinging Upon Instillation 0.4  (0.50) 0.6  (0.80)
Visit 4- Non-Instillation Burning/Stinging 0.0  (0.0) 0.1  (0.24)
Visit 4- Dry/Gritty Eye 0.2  (0.40) 0.4  (0.61)
Visit 4- Foreign Body Sensation 0.0  (0.0) 0.1  (0.33)
Visit 4- Eye Redness 0.2  (0.40) 0.2  (0.73)
Visit 4- Blurred Vision 0.1  (0.25) 0.1  (0.24)
Visit 4- Dry Mouth 0.4  (0.73) 0.4  (0.71)
Visit 4- Bad Taste/Change of Taste 0.0  (0.0) 0.3  (0.47)
Visit 4- Headache 0.0  (0.0) 0.1  (0.33)
Visit 4- Fatigue Malaise 0.0  (0.0) 0.1  (0.24)
Time Frame Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.
Adverse Event Reporting Description 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.
 
Arm/Group Title Combigan BID Simbrinza TID
Hide Arm/Group Description

Combigan 0.2%/0.5% one drop BID

Combigan BID

Simbrinza 1/0.2% one drop TID

Simbrinza TID

All-Cause Mortality
Combigan BID Simbrinza TID
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/22 (0.00%)    
Hide Serious Adverse Events
Combigan BID Simbrinza TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Combigan BID Simbrinza TID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/21 (14.29%)      3/22 (13.64%)    
Eye disorders     
Ocular Adverse Events   1/21 (4.76%)  1 2/22 (9.09%)  2
General disorders     
Non-ocular Adverse Events   2/21 (9.52%)  5 1/22 (4.55%)  1
Indicates events were collected by systematic assessment
The Local IRB closed in the middle of this trial which resulted in the discontinuation of 6 subjects. A new IRB was obtained and the study was re-opened and completed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Tepedino, MD
Organization: Cornerstone Healthcare
Phone: 336-802-2255
EMail: mtepedino@wakehealth.edu
Layout table for additonal information
Responsible Party: Michael Tepedino MD, Cornerstone Health Care, PA
ClinicalTrials.gov Identifier: NCT02167035    
Other Study ID Numbers: TEP001
First Submitted: June 12, 2014
First Posted: June 18, 2014
Results First Submitted: March 29, 2018
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018