Trial Outcomes & Findings for A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery (NCT NCT03035864)
NCT ID: NCT03035864
Last Updated: 2024-04-19
Results Overview
The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms. 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2024-04-19
Participant Flow
Eligible patients were randomized in a 2:1 ratio to rhNGF eye drops solution at 20 μg/ml (120 patients) or vehicle eye drops solution (60 patients) 6 times per day for 8 weeks, followed by 4 weeks of follow-up with no further treatment.
Participant milestones
| Measure |
rhNGF 20 µg/ml
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Treatment Period
STARTED
|
120
|
60
|
|
Treatment Period
COMPLETED
|
116
|
59
|
|
Treatment Period
NOT COMPLETED
|
4
|
1
|
|
Follow-up Period
STARTED
|
116
|
59
|
|
Follow-up Period
COMPLETED
|
105
|
55
|
|
Follow-up Period
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
| Measure |
rhNGF 20 µg/ml
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
0
|
|
Treatment Period
Other
|
3
|
1
|
|
Follow-up Period
Adverse Event
|
1
|
0
|
|
Follow-up Period
Lost to Follow-up
|
6
|
2
|
|
Follow-up Period
Physician Decision
|
1
|
0
|
|
Follow-up Period
Other
|
3
|
2
|
Baseline Characteristics
A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery
Baseline characteristics by cohort
| Measure |
rhNGF 20 µg/ml
n=115 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=59 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 12.80 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
115 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
115 participants
n=5 Participants
|
59 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set Population. Last observation carried forward (LOCF) imputation method
The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms. 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.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=112 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=58 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.
Frequency
|
-37.2 score on a scale
Standard Deviation 24.85
|
-35.7 score on a scale
Standard Deviation 26.04
|
|
Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.
Severity
|
-37.8 score on a scale
Standard Deviation 27.20
|
-37.3 score on a scale
Standard Deviation 20.43
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Full Analysis Set population. Last observation carried forward (LOCF) imputation method.
Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum \> 3 out of 15 is abnormal).
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=112 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=58 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
|
-2.5 score on a scale
Standard Deviation 2.11
|
-2.2 score on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: From baseline to weeks 4, 8 and 12Population: As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following: Week 4 - 110 rhNGF; 58 vehicle Week 8 - 107 rhNGF; 58 vehicle Week 12 - 107 rhNGF; 55 vehicle
Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots. Data for the main eye are reported.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=112 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=58 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
week 4
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
week 8
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
|
Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
week 12
|
0.0 units on a scale
Standard Deviation 0.00
|
0.0 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: From baseline to weeks 4, 8 and 12Population: As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following: Week 4 - 110 rhNGF Week 8 - 107 rhNGF Week 12 - 107 rhNGF
The TFBUT measurement was performed after instillation of 5 microliters of 2% 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. Data for the main eye are reported.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=112 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=58 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Changes in Tear Film Break-Up Time (TFBUT)
week 12
|
2.3 seconds
Standard Deviation 2.61
|
2.7 seconds
Standard Deviation 2.72
|
|
Changes in Tear Film Break-Up Time (TFBUT)
week 4
|
2.5 seconds
Standard Deviation 3.07
|
2.5 seconds
Standard Deviation 2.37
|
|
Changes in Tear Film Break-Up Time (TFBUT)
week 8
|
1.9 seconds
Standard Deviation 2.96
|
2.2 seconds
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: From baseline to week 8Population: As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied.
Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm. Data for the main eye are reported.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=107 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=58 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Changes in Cochet-Bonnet Corneal Aesthesiometry
inferior temporal
|
-0.1 cm
Standard Deviation 0.41
|
0.0 cm
Standard Deviation 0.64
|
|
Changes in Cochet-Bonnet Corneal Aesthesiometry
superior nasal
|
-0.1 cm
Standard Deviation 0.31
|
-0.2 cm
Standard Deviation 0.31
|
|
Changes in Cochet-Bonnet Corneal Aesthesiometry
inferior nasal
|
-0.2 cm
Standard Deviation 0.32
|
-0.1 cm
Standard Deviation 0.64
|
|
Changes in Cochet-Bonnet Corneal Aesthesiometry
superior temporal
|
-0.2 cm
Standard Deviation 0.36
|
-0.2 cm
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: From baseline to weeks 4, 8 and 12Population: Full Analysis Set Population. Observed values are reported.
The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms. 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.
Outcome measures
| Measure |
rhNGF 20 µg/ml
n=112 Participants
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=58 Participants
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Changes in SANDE Scores (Face Values) for Frequency and Severity
Frequency - week 4
|
-35.1 score on a scale
Standard Deviation 22.37
|
-33.2 score on a scale
Standard Deviation 25.18
|
|
Changes in SANDE Scores (Face Values) for Frequency and Severity
Frequency - week 8
|
-37.2 score on a scale
Standard Deviation 24.84
|
-35.7 score on a scale
Standard Deviation 26.04
|
|
Changes in SANDE Scores (Face Values) for Frequency and Severity
Frequency - week 12
|
-42.1 score on a scale
Standard Deviation 22.94
|
-38.6 score on a scale
Standard Deviation 26.25
|
|
Changes in SANDE Scores (Face Values) for Frequency and Severity
Severity - week 4
|
-35.7 score on a scale
Standard Deviation 24.28
|
-32.9 score on a scale
Standard Deviation 20.03
|
|
Changes in SANDE Scores (Face Values) for Frequency and Severity
Severity - week 8
|
-37.9 score on a scale
Standard Deviation 27.51
|
-37.3 score on a scale
Standard Deviation 20.43
|
|
Changes in SANDE Scores (Face Values) for Frequency and Severity
Severity - week 12
|
-43.5 score on a scale
Standard Deviation 22.7
|
-38.4 score on a scale
Standard Deviation 20.23
|
Adverse Events
rhNGF 20 µg/ml
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhNGF 20 µg/ml
n=115 participants at risk
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=59 participants at risk
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
Other adverse events
| Measure |
rhNGF 20 µg/ml
n=115 participants at risk
Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
rhNGF: Eye Drop 20 μg/mL
|
Vehicle
n=59 participants at risk
Vehicle eye drops six times daily
Vehicle: Vehicle Eye Drop
|
|---|---|---|
|
Eye disorders
Eye pain
|
20.0%
23/115 • Number of events 33 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
3.4%
2/59 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Eye irritation
|
11.3%
13/115 • Number of events 21 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
16.9%
10/59 • Number of events 12 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Vision blurred
|
6.1%
7/115 • Number of events 7 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
16.9%
10/59 • Number of events 12 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Myopia
|
8.7%
10/115 • Number of events 10 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
6.8%
4/59 • Number of events 4 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Dry eye
|
5.2%
6/115 • Number of events 8 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
10.2%
6/59 • Number of events 11 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Eye swelling
|
3.5%
4/115 • Number of events 5 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
3.4%
2/59 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
photophobia
|
2.6%
3/115 • Number of events 4 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
5.1%
3/59 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Eyelid oedema
|
2.6%
3/115 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
foreign body sensation in eyes
|
1.7%
2/115 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
1.7%
1/59 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Visual impairment
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
1.7%
1/59 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Diplopia
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
1.7%
1/59 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Eye pruritus
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
1.7%
1/59 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Ocular hyperaemia
|
1.7%
2/115 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/115 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
1.7%
1/59 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Conjunctival irritation
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Corneal epithelium defect
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Ocular discomfort
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Eye disorders
Photopsia
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Nervous system disorders
Headache
|
7.8%
9/115 • Number of events 14 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Nervous system disorders
Burning sensation
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Nervous system disorders
Dizziness
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/115 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
2/115 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Infections and infestations
Rhinitis
|
1.7%
2/115 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Infections and infestations
Influenza
|
1.7%
2/115 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Infections and infestations
Appendicitis
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Infections and infestations
Ear infection
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Infections and infestations
Sinusitis
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.87%
1/115 • Number of events 3 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Injury, poisoning and procedural complications
Eye burns
|
0.87%
1/115 • Number of events 2 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
General disorders
Fatigue
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
General disorders
Swelling
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/115 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
1.7%
1/59 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Psychiatric disorders
Anxiety
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.87%
1/115 • Number of events 1 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
0.00%
0/59 • Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)
Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.
|
Additional Information
Clinical Development & Operations
Dompé farmaceutici s.p.a.
Phone: +39 02 583831
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place