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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combigan Two Times Daily (BID) | Active Comparator | Combigan 0.2%/0.5% one drop Two Times Daily (BID) |
|
| Simbrinza Three Times Daily (TID) | Active Comparator | Simbrinza 1/0.2% one drop Three Times Daily (TID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combigan Two Times Daily (BID) | Drug |
| ||
| Simbrinza Three Times Daily (TID) |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Tepedino, MD | Cornerstone Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Health Care | High Point | North Carolina | 27262 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combigan Two Times Daily (BID) | Combigan 0.2%/0.5% one drop Two Times Daily (BID) Combigan Two Times Daily (BID) |
| FG001 | Simbrinza Three Times Daily (TID) | Simbrinza 1/0.2% one drop Three Times Daily (TID) Simbrinza Three Times Daily (TID) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was conducted on the Safety Population (N=43) for Subject Demographics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Combigan Twice Daily (BID) | Combigan 0.2%/0.5% one drop Twice Daily (BID) Combigan Twice Daily (BID) |
| BG001 | Simbrinza Three Times Daily (TID) | Simbrinza 1/0.2% one drop Three Times Daily (TID) Simbrinza Three Times Daily (TID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | mmHg | Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00) |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combigan BID | Combigan 0.2%/0.5% one drop BID Combigan BID | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Adverse Events | Eye disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Tepedino, MD | Cornerstone Healthcare | 336-802-2255 | mtepedino@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2016 | Mar 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2018 | Sep 6, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Drug |
|
| Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90) |
| Randomized to incorrect Study Medication |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Combigan BID | Combigan 0.2%/0.5% one drop Twice Daily (BID) Combigan Twice Daily (BID) |
| OG001 | Simbrinza TID | Simbrinza 1/0.2% one drop Three Times Daily (TID) Simbrinza Three Times Daily (TID) |
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90) |
|
|
|
| 21 |
| 0 |
| 21 |
| 3 |
| 21 |
| EG001 | Simbrinza TID | Simbrinza 1/0.2% one drop TID Simbrinza TID | 0 | 22 | 0 | 22 | 3 | 22 |
| Non-ocular Adverse Events | General disorders | Systematic Assessment |
|
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.
| Baseline - Dry/Gritty Eye |
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| Baseline - Foreign Body Sensation |
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| Baseline - Eye Redness |
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| Baseline - Blurred Vision |
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| Baseline - Dry Mouth |
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| Baseline - Bad Taste/change of taste |
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| Baseline - Headache |
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| Baseline - Fatigue Malaise |
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| Visit 2- Burning/Stinging Upon Instillation |
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| Visit 2- Non-Instillation Burning/Stinging |
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| Visit 2- Dry/Gritty Eye |
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| Visit 2- Foreign Body Sensation |
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| Visit 2- Eye Redness |
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| Visit 2- Blurred Vision |
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| Visit 2- Dry Mouth |
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| Visit 2- Bad Taste/Change of Taste |
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| Visit 2- Headache |
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| Visit 2- Fatique Malaise |
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| Visit 3- Burning/Stinging Upon Instillation |
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| Visit 3- Non-Instillation Burning/Stinging |
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| Visit 3- Dry/Gritty Eye |
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| Visit 3- Foreign Body Sensation |
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| Visit 3- Eye Redness |
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| Visit 3- Blurred Vision |
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| Visit 3- Dry Mouth |
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| Visit 3- Bad Taste/Change of Taste |
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| Visit 3- Headache |
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| Visit 3- Fatigue Malaise |
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| Visit 4- Burning/Stinging Upon Instillation |
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| Visit 4- Non-Instillation Burning/Stinging |
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| Visit 4- Dry/Gritty Eye |
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| Visit 4- Foreign Body Sensation |
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| Visit 4- Eye Redness |
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| Visit 4- Blurred Vision |
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| Visit 4- Dry Mouth |
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| Visit 4- Bad Taste/Change of Taste |
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| Visit 4- Headache |
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| Visit 4- Fatigue Malaise |
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