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An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye

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: NCT03019627
Recruitment Status : Completed
First Posted : January 12, 2017
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye
Interventions Drug: NGF
Other: Vehicle
Enrollment 150
Recruitment Details After confirmation of inclusion and exclusion criteria all eligible patients were randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up. rhNGF and vehicle were administered as eye drops at 20 μg/mL concentration, six times daily for 8 weeks in patients with dry eye
Pre-assignment Details  
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Period Title: Overall Study
Started 100 50
Completed 85 42
Not Completed 15 8
Reason Not Completed
Adverse Event             8             0
Unrelated to adverse event             1             3
Lost to Follow-up             2             1
not compliance             2             2
not specified             2             2
Arm/Group Title rhNGF 20μg/mL Vehicle Total
Hide Arm/Group Description

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Total of all reporting groups
Overall Number of Baseline Participants 100 50 150
Hide Baseline Analysis Population Description
Enrolled set = All patients who were randomized comprised the Enrolled Set. Data from this set was used to summarize demographic, baseline, and background characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 50 participants 150 participants
57.5  (11.89) 57.7  (10.33) 57.5  (11.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
Female
85
  85.0%
46
  92.0%
131
  87.3%
Male
15
  15.0%
4
   8.0%
19
  12.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
Hispanic or Latino
1
   1.0%
2
   4.0%
3
   2.0%
Not Hispanic or Latino
99
  99.0%
48
  96.0%
147
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 50 participants 150 participants
100 50 150
Number of baseline participants  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
100
 100.0%
50
 100.0%
150
 100.0%
1.Primary Outcome
Title Symptom Assessment in Dry Eye (SANDE) Scores
Hide Description

Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts.

The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description:

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Overall Number of Participants Analyzed 97 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Frequency Number Analyzed 96 participants 48 participants
-38.8  (28.97) -34.0  (26.67)
Severity Number Analyzed 97 participants 48 participants
-32.2  (31.04) -31.07  (28.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Frequency statistical analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.428
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value -3.83
Confidence Interval (2-Sided) 95%
-13.34 to 5.68
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Severity statistical analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.974
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-9.45 to 9.76
Estimation Comments [Not Specified]
2.Secondary Outcome
Title SANDE Scores
Hide Description

Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts.

The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

Time Frame Week 4, week 8, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description:

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Overall Number of Participants Analyzed 97 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Frequency - week 4 Number Analyzed 94 participants 47 participants
-22.1  (24.08) -20.4  (20.66)
Frequency - week 8 Number Analyzed 86 participants 42 participants
-39.6  (28.55) -34.6  (27.60)
Frequency - week 12 Number Analyzed 88 participants 42 participants
-44.8  (28.69) -28.2  (28.94)
Severity - week 4 Number Analyzed 94 participants 47 participants
-19.9  (25.20) -22.2  (24.31)
Severity - week 8 Number Analyzed 86 participants 42 participants
-32.6  (30.64) -33.1  (28.30)
Severity - week 12 Number Analyzed 88 participants 42 participants
-38.8  (29.20) -24.3  (28.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments frequency statistical analysis - week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.783
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -1.12
Confidence Interval (2-Sided) 95%
-9.14 to 6.91
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Frequency statistical analysis - week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.461
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value -3.82
Confidence Interval (2-Sided) 95%
-14.1 to 6.41
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Frequency statistical analysis - week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value -15.3
Confidence Interval (2-Sided) 95%
-25.6 to -4.97
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Severity statistical analysis - week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.544
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value 2.55
Confidence Interval (2-Sided) 95%
-5.72 to 10.82
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Severity statistical analysis - week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.837
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
-9.12 to 11.24
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments Severity statistical analysis - week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in least square means
Estimated Value -13.8
Confidence Interval (2-Sided) 95%
-23.7 to 3.88
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Cornea Vital Staining
Hide Description

Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15.

Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).

Briefly, grade 0 reflected normal/healthy situation, whereas grade 3 reflected a severe damage in the considered sector.

Time Frame week 4, week 8, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description:

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Overall Number of Participants Analyzed 97 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 4 Number Analyzed 94 participants 47 participants
-3.5  (2.32) -3.0  (2.27)
week 8 Number Analyzed 86 participants 41 participants
-4.2  (2.92) -4.4  (2.70)
week 12 Number Analyzed 88 participants 42 participants
-4.4  (2.80) -5.1  (2.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.046
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.38 to -0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.425
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-1.05 to 0.44
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.788
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.76 to 0.58
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Conjunctival Vital Staining
Hide Description

Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15.

Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).

Briefly, grade 0 reflected normal/healthy situation, whereas grade 3 reflected a severe damage in the considered sector.

Time Frame week 4, week 8, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description:

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Overall Number of Participants Analyzed 97 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 4 Number Analyzed 94 participants 47 participants
-4.7  (3.94) -4.1  (3.45)
week 8 Number Analyzed 86 participants 42 participants
-6.7  (4.16) -5.9  (4.07)
week 12 Number Analyzed 88 participants 42 participants
-7.2  (4.23) -7.0  (3.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.265
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.95 to 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.026
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -1.38
Confidence Interval (2-Sided) 95%
-2.59 to -0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.361
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-1.90 to 0.70
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Tear Film Break-up Time (TFBUT)
Hide Description TFBUT was measured by determining the time to tear break-up. The TFBUT was performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.
Time Frame week 4, week 8, week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description:

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Overall Number of Participants Analyzed 97 48
Mean (Standard Deviation)
Unit of Measure: seconds
week 4 Number Analyzed 94 participants 47 participants
0.4  (1.68) 0.8  (1.57)
week 8 Number Analyzed 86 participants 42 participants
0.5  (1.74) 0.7  (1.89)
week 12 Number Analyzed 88 participants 42 participants
0.5  (2.34) 0.9  (1.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.323
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.76 to 0.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.908
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.55 to 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.702
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.76 to 0.52
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Wetting Distance
Hide Description The Schirmer test without anesthesia was performed to measure aqueous tear secretion prior to the instillation of any dilating or eye drops
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description:

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

Overall Number of Participants Analyzed 85 42
Mean (Standard Deviation)
Unit of Measure: millimeters
2.4  (11.41) -3.1  (8.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rhNGF 20μg/mL, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in least square means
Estimated Value 5.75
Confidence Interval (2-Sided) 95%
2.02 to 9.48
Estimation Comments [Not Specified]
Time Frame Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and ETV or early termination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rhNGF 20μg/mL Vehicle
Hide Arm/Group Description

Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily

NGF: Eye Drop 20 μg/mL

vehicle eye drops six times daily

Vehicle: Vehicle Eye Drop

All-Cause Mortality
rhNGF 20μg/mL Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/50 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
rhNGF 20μg/mL Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/100 (5.00%)      0/50 (0.00%)    
Cardiac disorders     
Atrial fibrillation  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Infections and infestations     
Diverticulitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Upper respiratory tract infection  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Nervous system disorders     
Paraesthesia  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/100 (1.00%)  1 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
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 1%
rhNGF 20μg/mL Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/100 (97.00%)      38/50 (76.00%)    
Cardiac disorders     
Atrial fibrillation  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Palpitations  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Vertigo  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Eye disorders     
Ocular discomfort  1  69/100 (69.00%)  87 10/50 (20.00%)  17
Eye pain  1  42/100 (42.00%)  67 4/50 (8.00%)  4
Eye irritation  1  15/100 (15.00%)  19 10/50 (20.00%)  11
Vision blurred  1  13/100 (13.00%)  14 4/50 (8.00%)  6
Photophobia  1  12/100 (12.00%)  14 3/50 (6.00%)  3
Eye pruritus  1  8/100 (8.00%)  8 5/50 (10.00%)  5
Eye discharge  1  9/100 (9.00%)  13 1/50 (2.00%)  2
Eyelid disorder  1  8/100 (8.00%)  8 0/50 (0.00%)  0
Eyelid oedema  1  4/100 (4.00%)  6 1/50 (2.00%)  3
Dry eye  1  4/100 (4.00%)  4 1/50 (2.00%)  1
Eyelid pain  1  5/100 (5.00%)  5 0/50 (0.00%)  0
Lacrimation increased  1  3/100 (3.00%)  3 2/50 (4.00%)  2
Ocular hyperaemia  1  3/100 (3.00%)  8 1/50 (2.00%)  1
Blepharospasm  1  2/100 (2.00%)  3 2/50 (4.00%)  2
Eye swelling  1  4/100 (4.00%)  5 0/50 (0.00%)  0
Eyelid margin crusting  1  2/100 (2.00%)  2 1/50 (2.00%)  2
Foreign body sensation in eyes  1  3/100 (3.00%)  4 0/50 (0.00%)  0
Abnormal sensation in eye  1  1/100 (1.00%)  1 2/50 (4.00%)  2
Eyelid pruritus  1  2/100 (2.00%)  4 0/50 (0.00%)  0
Asthenopia  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Conjunctival haemorrhage  1  1/100 (1.00%)  1 1/50 (2.00%)  1
Diplopia  1  1/100 (1.00%)  1 1/50 (2.00%)  1
Eye allergy  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Scleral haemorrhage  1  1/100 (1.00%)  1 1/50 (2.00%)  1
visual impairment  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Vitreous floaters  1  1/100 (1.00%)  1 1/50 (2.00%)  1
Eye paraesthesia  1  1/100 (1.00%)  3 0/50 (0.00%)  0
Conjunctival deposit  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Conjunctivitis allergic  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Corneal oedema  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Eye inflammation  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Eyelid irritation  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Eyelid sensory disorder  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Lacrimation decreased  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Photopsia  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Scleral discolouration  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Gastrointestinal disorders     
abdominal discomfort  1  2/100 (2.00%)  2 1/50 (2.00%)  1
Diarrhoea  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Abdominal pain upper  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Diverticulum  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Dry mouth  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Glossodynia  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Nausea  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Salivary gland calculus  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Stomatitis  1  0/100 (0.00%)  0 1/50 (2.00%)  1
General disorders     
Sensation of foreign body  1  2/100 (2.00%)  2 1/50 (2.00%)  1
Pyrexia  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Fatigue  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Generalized oedema  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Humidity intolerance  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Oedema peripheral  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Pain  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Temperature intolerance  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Immune system disorders     
Seasonal allergy  1  3/100 (3.00%)  3 0/50 (0.00%)  0
Hypersensivity  1  1/100 (1.00%)  2 0/50 (0.00%)  0
Graft versus host disease  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Multiple allergies  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Infections and infestations     
Viral upper respiratory tract infection  1  8/100 (8.00%)  10 5/50 (10.00%)  5
Sinusitis  1  2/100 (2.00%)  2 1/50 (2.00%)  2
Bronchitis  1  0/100 (0.00%)  0 2/50 (4.00%)  2
Upper respiratory tract infection  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Acute sinusitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Cellulitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Conjunctivitis  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Conjunctivitis viral  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Diverticulitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Ear infection  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Fungal infection  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Herpes simplex  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Herpes virus infection  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Influenza  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Nasopharyngitis  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Ophthalmic herpes simplex  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Pertussis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Pharyngitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Pneumonia  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Pyelonephritis acute  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Vaginal infection  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Injury, poisoning and procedural complications     
Foreign body in eye  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Superficial injury of eye  1  1/100 (1.00%)  1 1/50 (2.00%)  1
Contusion  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Eye burns  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Eye contusion  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Eye injury  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Fall  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Investigations     
Intraocular pressure test  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Metabolism and nutrition disorders     
Glucose tolerance impaired  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Iron deficiency  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  2/100 (2.00%)  2 1/50 (2.00%)  2
Pain in extremity  1  1/100 (1.00%)  1 2/50 (4.00%)  2
Arthralgia  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Bursitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Intervertebral disc disorder  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Joint stiffness  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Muscle spasms  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Myalgia  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Myofascial pain syndrome  1  1/100 (1.00%)  1 0/50 (0.00%)  0
plantar fasciitis  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Rotator cuff syndrome  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Tendonitis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Nervous system disorders     
Headache  1  12/100 (12.00%)  14 5/50 (10.00%)  11
Migrane  1  3/100 (3.00%)  3 0/50 (0.00%)  0
Burning sensation  1  1/100 (1.00%)  1 1/50 (2.00%)  1
Paraesthesia  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Autonomic failure syndrome  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Cervical Myelopathy  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Dizziness  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Dysarthria  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Hypoaesthesia  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Neuralgia  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Polyneuropathy idiopathic progressive  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Sciatica  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Sinus headache  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Psychiatric disorders     
Depression  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Insomnia  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Panic attack  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Renal and urinary disorders     
Lupus nephritis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal discomfort  1  3/100 (3.00%)  3 0/50 (0.00%)  0
Oropharyngeal pain  1  3/100 (3.00%)  3 0/50 (0.00%)  0
Cough  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Sinus congestion  1  2/100 (2.00%)  2 0/50 (0.00%)  0
Asthma  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Asthma exercise induced  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Dry throat  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Haemoptysis  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Nasal congestion  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Nasal dryness  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Nasal inflammation  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Skin and subcutaneous tissue disorders     
Urticaria  1  1/100 (1.00%)  1 3/50 (6.00%)  8
Pruritus  1  1/100 (1.00%)  1 1/50 (2.00%)  1
Madarosis  1  1/100 (1.00%)  2 0/50 (0.00%)  0
Acne  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Erythema  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Skin discolouration  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Skin irritation  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Surgical and medical procedures     
Dental implantation  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Endodontic procedure  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Eye laser surgery  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Haemorrhoid operation  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Tooth extraction  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Vena cava filter removal  1  0/100 (0.00%)  0 1/50 (2.00%)  1
Vascular disorders     
Raynaud's phenomenon  1  1/100 (1.00%)  1 0/50 (0.00%)  0
Vein disorder  1  1/100 (1.00%)  1 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
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: Valeria Motta, PhD
Organization: Dompé
Phone: 02583831
EMail: info@dompe.it
Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT03019627     History of Changes
Other Study ID Numbers: NGF0216
First Submitted: January 11, 2017
First Posted: January 12, 2017
Results First Submitted: October 19, 2018
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019