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Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02547623
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : June 19, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
ICON Bioscience Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataract
Interventions Drug: Dexamethasone
Drug: Prednisolone
Enrollment 194
Recruitment Details The first patient was enrolled into the study on 06 November 2015 and the last patient completed the study on 16 August 2016.
Pre-assignment Details Of the 194 patients randomized, 181 patients were dosed and included in the ITT (intent-to-treat) and safety analysis sets. 13 randomized patients were not dosed and terminated from the study. Some of the patients that were not dosed had at least one significant protocol deviation.
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Period Title: Overall Study
Started 126 55
Completed 122 52
Not Completed 4 3
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care) Total
Hide Arm/Group Description A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks) Total of all reporting groups
Overall Number of Baseline Participants 126 55 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 55 participants 181 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  27.0%
17
  30.9%
51
  28.2%
>=65 years
92
  73.0%
38
  69.1%
130
  71.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 55 participants 181 participants
Female
67
  53.2%
31
  56.4%
98
  54.1%
Male
59
  46.8%
24
  43.6%
83
  45.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 55 participants 181 participants
Hispanic or Latino
9
   7.1%
1
   1.8%
10
   5.5%
Not Hispanic or Latino
117
  92.9%
54
  98.2%
171
  94.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 55 participants 181 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   0.8%
2
   3.6%
3
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
   8.7%
1
   1.8%
12
   6.6%
White
111
  88.1%
52
  94.5%
163
  90.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.4%
0
   0.0%
3
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 126 participants 55 participants 181 participants
126
 100.0%
55
 100.0%
181
 100.0%
Study Eye  
Measure Type: Number
Unit of measure:  Study eye
Number Analyzed 126 participants 55 participants 181 participants
OD (Right eye) 67 27 94
OS (Left eye) 59 28 87
Best Corrected Visual Acuity   [1] 
Mean (Standard Deviation)
Unit of measure:  LogMar
Number Analyzed 126 participants 55 participants 181 participants
study eye number .292  (.1913) .355  (.2557) .311  (.2141)
fellow eye number .126  (.1394) .176  (.2123) .141  (.1660)
[1]
Measure Description: Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1
Corneal Endothelial Cell Density - Specular Microscopy  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^2
Number Analyzed 126 participants 55 participants 181 participants
2491.91  (346.365) 2398.33  (384.092) 2463.15  (359.902)
Intraocular Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 126 participants 55 participants 181 participants
Study eye 15.1  (2.94) 14.4  (2.71) 14.9  (2.88)
Fellow eye 14.9  (2.88) 14.5  (2.79) 14.8  (2.85)
Use of Viscoelastic during the Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 55 participants 181 participants
Yes
126
 100.0%
55
 100.0%
181
 100.0%
No
0
   0.0%
0
   0.0%
0
   0.0%
Use of Femto prior to the Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 55 participants 181 participants
Yes
25
  19.8%
8
  14.5%
33
  18.2%
No
101
  80.2%
47
  85.5%
148
  81.8%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
Time Frame Baseline to postoperative day 90/ early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Ocular events: study eye Any TEAE
53
  42.1%
13
  23.6%
Serious TEAE
1
   0.8%
0
   0.0%
No TEAE
72
  57.1%
42
  76.4%
Ocular events: fellow eye Any TEAE
12
   9.5%
4
   7.3%
Serious TEAE
0
   0.0%
0
   0.0%
No TEAE
114
  90.5%
51
  92.7%
Systemic events Any TEAE
10
   7.9%
6
  10.9%
Serious TEAE
2
   1.6%
0
   0.0%
No TEAE
114
  90.5%
49
  89.1%
2.Secondary Outcome
Title Intraocular Pressure Measurement
Hide Description Intraocular Pressure was measured by Goldmann applanation tonometry.
Time Frame Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Mean (Standard Deviation)
Unit of Measure: mmHG
Screening (Baseline) 15.1  (2.94) 14.4  (2.71)
Post Operative Day 1 19.1  (6.54) 17.5  (6.44)
Post Operative Day 8 15.0  (4.7) 15.1  (3.64)
Post Operative Day 30 13.8  (3.2) 14.1  (3.57)
Post Operative Day 90/End of Treatment 13.0  (2.89) 12.7  (2.93)
3.Secondary Outcome
Title Visual Acuity in Study Eye
Hide Description Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1
Time Frame Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Mean (Standard Deviation)
Unit of Measure: LogMar
Screening (Baseline) .292  (0.1913) .355  (.2557)
Post Operative Day 1 .249  (.1398) .327  (.2129)
Post Operative Day 8 .073  (.1353) .073  (.1746)
Post Operative Day 30 .039  (.0952) .040  (.1350)
Post Operative Day 90/End of Treatment .040  (.1012) .047  (.1150)
4.Secondary Outcome
Title Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
Hide Description

Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator’s standard slit lamp equipment and procedure.

Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.

Time Frame Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline 0 (Absent)
124
  98.4%
55
 100.0%
1 (Mild)
1
   0.8%
0
   0.0%
2 (Moderate)
1
   0.8%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
0
   0.0%
0
   0.0%
Postoperative day 1 0 (Absent)
103
  81.7%
45
  81.8%
1 (Mild)
21
  16.7%
10
  18.2%
2 (Moderate)
2
   1.6%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
0
   0.0%
0
   0.0%
Postoperative day 8 0 (Absent)
115
  91.3%
45
  81.8%
1 (Mild)
11
   8.7%
8
  14.5%
2 (Moderate)
0
   0.0%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
0
   0.0%
2
   3.6%
Postoperative day 30 0 (Absent)
107
  84.9%
44
  80.0%
1 (Mild)
14
  11.1%
8
  14.5%
2 (Moderate)
2
   1.6%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
3
   2.4%
3
   5.5%
Postoperative day 90/End of Treatment 0 (Absent)
119
  94.4%
50
  90.9%
1 (Mild)
4
   3.2%
2
   3.6%
2 (Moderate)
0
   0.0%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
3
   2.4%
3
   5.5%
5.Secondary Outcome
Title Slit Lamp Biomicroscopy - Cornea Edema Grade
Hide Description

Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator’s standard slit lamp equipment and procedure.

Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.

Time Frame Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline 0 (Absent)
126
 100.0%
54
  98.2%
1 (Mild)
0
   0.0%
0
   0.0%
2 (Moderate)
0
   0.0%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
0
   0.0%
1
   1.8%
Postoperative day 1 0 (Absent)
74
  58.7%
37
  67.3%
1 (Mild)
43
  34.1%
15
  27.3%
2 (Moderate)
9
   7.1%
3
   5.5%
3 (Severe)
0
   0.0%
0
   0.0%
No value
0
   0.0%
0
   0.0%
Postoperative day 8 0 (Absent)
109
  86.5%
48
  87.3%
1 (Mild)
16
  12.7%
6
  10.9%
2 (Moderate)
0
   0.0%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
1
   0.8%
1
   1.8%
Postoperative day 30 0 (Absent)
121
  96.0%
52
  94.5%
1 (Mild)
0
   0.0%
0
   0.0%
2 (Moderate)
2
   1.6%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
3
   2.4%
3
   5.5%
Postoperative day 90/End of Treatment 0 (Absent)
123
  97.6%
52
  94.5%
1 (Mild)
0
   0.0%
0
   0.0%
2 (Moderate)
0
   0.0%
0
   0.0%
3 (Severe)
0
   0.0%
0
   0.0%
No value
3
   2.4%
3
   5.5%
6.Secondary Outcome
Title Summary of Concomitant Medications Used in the Study Eye or Both Eyes
Hide Description [Not Specified]
Time Frame Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Patients reporting at least one concomitant medica
124
  98.4%
55
 100.0%
Antiseptics and disinfectants
1
   0.8%
1
   1.8%
Anesthetics
4
   3.2%
1
   1.8%
Psycholeptics
2
   1.6%
1
   1.8%
Ophthalmologicals
124
  98.4%
55
 100.0%
Thyroid therapy
0
   0.0%
1
   1.8%
7.Secondary Outcome
Title Changes in the Corneal Endothelial Cell Count
Hide Description Corneal Endothelial Cell Density was measured by specular microscopy.
Time Frame Baseline, Postoperative day 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Mean (Standard Deviation)
Unit of Measure: cells/mm^2
Baseline 2483.66  (351.819) 2398.33  (384.092)
Postoperative day 90/End of treatment 2141.77  (522.327) 2106.39  (517.938)
Change from Baseline -334.60  (415.071) -288.83  (376.775)
8.Secondary Outcome
Title Optic Disc Cup-disc Ratio for the Study Eye
Hide Description Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).
Time Frame Baseline, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Mean (Standard Deviation)
Unit of Measure: ratio
Screening (Baseline) .31  (.142) .32  (.135)
Postoperative day 90/End of treatment .31  (.131) .33  (.143)
9.Secondary Outcome
Title Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
Hide Description The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc
Time Frame Baseline, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Screening (Baseline) Normal
115
  91.3%
52
  94.5%
Abnormal
2
   1.6%
1
   1.8%
Not analyzed
9
   7.1%
2
   3.6%
Postoperative day 90/End of treatment Normal
119
  94.4%
50
  90.9%
Abnormal
2
   1.6%
1
   1.8%
Not analyzed
5
   4.0%
4
   7.3%
10.Secondary Outcome
Title Dilated Opthalmoscopy Findings - Retina (Study Eye)
Hide Description The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina
Time Frame Baseline, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Screening (Baseline) Normal
120
  95.2%
51
  92.7%
Abnormal
5
   4.0%
4
   7.3%
Not analyzed
1
   0.8%
0
   0.0%
Postoperative day 90/End of treatment Normal
118
  93.7%
50
  90.9%
Abnormal
5
   4.0%
1
   1.8%
Not analyzed
3
   2.4%
4
   7.3%
11.Secondary Outcome
Title Dilated Opthalmoscopy Findings - Macula (Study Eye)
Hide Description The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.
Time Frame Baseline, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Screening (Baseline) Normal
109
  86.5%
44
  80.0%
Abnormal
15
  11.9%
11
  20.0%
Not analyzed
2
   1.6%
0
   0.0%
Postoperative day 90/End of treatment Normal
107
  84.9%
39
  70.9%
Abnormal
16
  12.7%
12
  21.8%
Not analyzed
3
   2.4%
4
   7.3%
12.Secondary Outcome
Title Dilated Opthalmoscopy Findings - Choroid (Study Eye)
Hide Description The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid
Time Frame Baseline, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Screening (Baseline) Normal
124
  98.4%
54
  98.2%
Abnormal
0
   0.0%
0
   0.0%
Not analyzed
2
   1.6%
1
   1.8%
Postoperative day 90/End of treatment Normal
122
  96.8%
50
  90.9%
Abnormal
1
   0.8%
0
   0.0%
Not analyzed
3
   2.4%
5
   9.1%
13.Secondary Outcome
Title Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
Hide Description The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous
Time Frame Baseline, POD 90/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description:
A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery
Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
Overall Number of Participants Analyzed 126 55
Measure Type: Count of Participants
Unit of Measure: Participants
Screening (Baseline) Normal
104
  82.5%
49
  89.1%
Abnormal
21
  16.7%
5
   9.1%
Not analyzed
1
   0.8%
1
   1.8%
Postoperative day 90/End of treatment Normal
107
  84.9%
44
  80.0%
Abnormal
16
  12.7%
7
  12.7%
Not analyzed
3
   2.4%
4
   7.3%
Time Frame Adverse event data was collected from screening until postoperative day 90/end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Hide Arm/Group Description A single intraocular dose of dexamethasone (517 mcg) at the conclusion of cataract surgery Three weeks of treatment with prednisolone drops 1% (one drop, four times daily for three weeks)
All-Cause Mortality
Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/55 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/126 (2.38%)   0/55 (0.00%) 
Eye disorders     
Diabetic retinopathy   1/126 (0.79%)  0/55 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia   1/126 (0.79%)  0/55 (0.00%) 
Nervous system disorders     
Loss of consciousness   1/126 (0.79%)  0/55 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dexamethasone Depot Prednisolone Drops 1% (Standard of Care)
Affected / at Risk (%) Affected / at Risk (%)
Total   23/126 (18.25%)   6/55 (10.91%) 
Eye disorders     
Iritis   8/126 (6.35%)  0/55 (0.00%) 
Investigations     
Intraocular pressure increased   14/126 (11.11%)  2/55 (3.64%) 
Nervous system disorders     
Headache   1/126 (0.79%)  4/55 (7.27%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Vice President, Quality and Compliance
Organization: Icon Bioscience, Inc.
Phone: 510-933-8381
Responsible Party: ICON Bioscience Inc
ClinicalTrials.gov Identifier: NCT02547623     History of Changes
Other Study ID Numbers: C15-01
First Submitted: September 9, 2015
First Posted: September 11, 2015
Results First Submitted: April 6, 2018
Results First Posted: June 19, 2018
Last Update Posted: August 21, 2018