Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers (NCT NCT01744704)
NCT ID: NCT01744704
Last Updated: 2024-04-19
Results Overview
A global ocular discomfort score was determined using a 100 mm visual analogue scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. This evaluation was performed before any ophthalmic assessment at a given study visit. Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. Part 0: VAS evaluated on days -1, 1, 3, 10 (FU) Part A: VAS evaluated on days -1, 1, 3, 10 (FU) Part B: VAS evaluated on days -1, 1, 5, 15 (FU) Follow up (FU) refers to participants' last available assessment. The Outcome Measure Time Points and Data Table refers to Part B.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
Day -1, Day 1, Day 5, Day 15 (FU)
Results posted on
2024-04-19
Participant Flow
Participant milestones
| Measure |
rhNGF 0.5 µg/mL Sentinel
1 x 35 µL drop 3 subjects
rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
1 x 35 µL drop 3 subjects
rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
1 x 35 µL drop 3 subjects
rhNGF 20 µg/mL Sentinel
|
rhNGF 60 µg/mL Part A
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 60 µg/mL Part A
|
rhNGF 20 µg/mL Part A
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 20 µg/mL Part A
|
rhNGF 180 µg/mL Part A
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 180 µg/mL Part A
|
Placebo Part A
3 x 35 µL drops applied at 4 h intervals 6 subjects
Placebo Part A
|
rhNGF 20 µg/mL Part B
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 20 µg/mL Part B Cohort 0M
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 3 subjects
rhNGF 20 µg/mL Part B cohort 0M
|
rhNGF 60 µg/mL Part B
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
6
|
7
|
6
|
9
|
3
|
9
|
9
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
6
|
7
|
6
|
9
|
3
|
9
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Safety, Tolerability and Pharmacokinetics of rhNGF Eye Drops in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects
rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects
rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects
rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects
Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 7 • n=99 Participants
|
47 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
29 years
STANDARD_DEVIATION 11.9 • n=206 Participants
|
46 years
STANDARD_DEVIATION 10 • n=7 Participants
|
36 years
STANDARD_DEVIATION 9.4 • n=31 Participants
|
42 years
STANDARD_DEVIATION 17.8 • n=30 Participants
|
42 years
STANDARD_DEVIATION 9 • n=3 Participants
|
41 years
STANDARD_DEVIATION 12.1 • n=6 Participants
|
36 years
STANDARD_DEVIATION 14.7 • n=114 Participants
|
29 years
STANDARD_DEVIATION 10.3
|
36 years
STANDARD_DEVIATION 12.6 • n=19 Participants
|
40.2 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
1 Participants
|
2 Participants
n=19 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
8 Participants
|
8 Participants
n=19 Participants
|
50 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
0 participants
n=30 Participants
|
0 participants
n=3 Participants
|
3 participants
n=6 Participants
|
9 participants
n=114 Participants
|
9 participants
|
8 participants
n=19 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
7 participants
n=30 Participants
|
6 participants
n=3 Participants
|
9 participants
n=6 Participants
|
0 participants
n=114 Participants
|
0 participants
|
2 participants
n=19 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day -1, Day 1, Day 5, Day 15 (FU)Population: Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.
A global ocular discomfort score was determined using a 100 mm visual analogue scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. This evaluation was performed before any ophthalmic assessment at a given study visit. Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia. Part 0: VAS evaluated on days -1, 1, 3, 10 (FU) Part A: VAS evaluated on days -1, 1, 3, 10 (FU) Part B: VAS evaluated on days -1, 1, 5, 15 (FU) Follow up (FU) refers to participants' last available assessment. The Outcome Measure Time Points and Data Table refers to Part B.
Outcome measures
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Changes in VAS Ocular Tolerability
Foreign body sensation - Day 1 (8h) vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
3 units on a scale
Standard Deviation 7.3
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0.4 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.8
|
|
Changes in VAS Ocular Tolerability
Foreign body sensation - Day 5 vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
1 units on a scale
Standard Deviation 2.6
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.7
|
|
Changes in VAS Ocular Tolerability
Foreign body sensation - FU vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.6
|
|
Changes in VAS Ocular Tolerability
Burning/Stinging - Day 1 (8h) vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.6
|
2 units on a scale
Standard Deviation 4.9
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0.3
|
|
Changes in VAS Ocular Tolerability
Itching - Day 1 (8h) vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.4
|
|
Changes in VAS Ocular Tolerability
Itching - Day 5 vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.5
|
|
Changes in VAS Ocular Tolerability
Itching - FU vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0
|
|
Changes in VAS Ocular Tolerability
Pain - Day 1 (8h) vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.8
|
|
Changes in VAS Ocular Tolerability
Pain - Day 5 vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
1 units on a scale
Standard Deviation 3.5
|
4 units on a scale
Standard Deviation 6.5
|
0 units on a scale
Standard Deviation 1.1
|
|
Changes in VAS Ocular Tolerability
Pain - FU vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.7
|
|
Changes in VAS Ocular Tolerability
Sticky feeling - Day 1 (8h) vs Day -1
|
-1 units on a scale
Standard Deviation 1.7
|
0 units on a scale
Standard Deviation 0
|
-3 units on a scale
Standard Deviation 4.6
|
-1 units on a scale
Standard Deviation 1.6
|
0 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0
|
1 units on a scale
Standard Deviation 2.4
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.7
|
3 units on a scale
Standard Deviation 7.6
|
0 units on a scale
Standard Deviation 0.4
|
|
Changes in VAS Ocular Tolerability
Sticky feeling - Day 5 vs Day -1
|
-1 units on a scale
Standard Deviation 1.7
|
0 units on a scale
Standard Deviation 0
|
-2 units on a scale
Standard Deviation 4.9
|
-1 units on a scale
Standard Deviation 1.6
|
0 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.5
|
1 units on a scale
Standard Deviation 3.6
|
0 units on a scale
Standard Deviation 0.6
|
|
Changes in VAS Ocular Tolerability
Blurred vision - Day 5 vs Day -1
|
-2 units on a scale
Standard Deviation 1.5
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.5
|
|
Changes in VAS Ocular Tolerability
Blurred vision - FU vs Day -1
|
-2 units on a scale
Standard Deviation 1.5
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.3
|
1 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.5
|
|
Changes in VAS Ocular Tolerability
Photophobia - Day 1 (8h) vs Day -1
|
-1 units on a scale
Standard Deviation 1.7
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
1 units on a scale
Standard Deviation 3.3
|
1 units on a scale
Standard Deviation 1.6
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0.5
|
|
Changes in VAS Ocular Tolerability
Photophobia - Day 5 vs Day -1
|
-1 units on a scale
Standard Deviation 1.7
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.6
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.8
|
1 units on a scale
Standard Deviation 2.0
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.5
|
|
Changes in VAS Ocular Tolerability
Photophobia - FU vs Day -1
|
-1 units on a scale
Standard Deviation 1.7
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.7
|
0 units on a scale
Standard Deviation 0.5
|
|
Changes in VAS Ocular Tolerability
Burning/Stinging - Day 5 vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
1 units on a scale
Standard Deviation 3.5
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.4
|
|
Changes in VAS Ocular Tolerability
Burning/Stinging - FU vs Day -1
|
-1 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.6
|
|
Changes in VAS Ocular Tolerability
Sticky feeling - FU vs Day -1
|
-1 units on a scale
Standard Deviation 1.7
|
0 units on a scale
Standard Deviation 0
|
-3 units on a scale
Standard Deviation 4.6
|
-1 units on a scale
Standard Deviation 1.6
|
0 units on a scale
Standard Deviation 0.8
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0.3
|
|
Changes in VAS Ocular Tolerability
Blurred vision - Day 1 (8h) vs Day -1
|
-2 units on a scale
Standard Deviation 1.5
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.4
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0.5
|
0 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: Day -1, Day 1, Day 5, Day 15 (FU)Population: Safety population consisted of all subjects randomised into the study and receiving a dose of study medication.
Best corrected distance visual acuity measured using the ETDRS (Early Treatment Diabetic Retinopathy Study) score. In this population, the scores range from -6 (worse visus) to 3 (best visus). The study includes Part 0, Part A and Part B. In Part B BCDVA was evaluated on days -1, 1, 5, 15 (FU). Follow up (FU) refers to participants' last available assessment.
Outcome measures
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Best Corrected Distance Visual Acuity (BCDVA)
Day 1 vs Day-1
|
1 units on a scale
Standard Deviation 0.6
|
3 units on a scale
Standard Deviation 0.6
|
-6 units on a scale
Standard Deviation 3.1
|
3 units on a scale
Standard Deviation 1.6
|
0 units on a scale
Standard Deviation 0.4
|
-0 units on a scale
Standard Deviation 1.4
|
1 units on a scale
Standard Deviation 1.6
|
1 units on a scale
Standard Deviation 2.7
|
0 units on a scale
Standard Deviation 3.7
|
0 units on a scale
Standard Deviation 3.6
|
0 units on a scale
Standard Deviation 3.1
|
|
Change in Best Corrected Distance Visual Acuity (BCDVA)
Day 5 vs Day-1
|
1 units on a scale
Standard Deviation 2.3
|
0.0 units on a scale
Standard Deviation 4.7
|
1 units on a scale
Standard Deviation 2.1
|
1 units on a scale
Standard Deviation 2.6
|
1 units on a scale
Standard Deviation 2.5
|
0 units on a scale
Standard Deviation 2.8
|
-1 units on a scale
Standard Deviation 2.0
|
1 units on a scale
Standard Deviation 2.7
|
1 units on a scale
Standard Deviation 2.9
|
0 units on a scale
Standard Deviation 3.3
|
0 units on a scale
Standard Deviation 3.8
|
|
Change in Best Corrected Distance Visual Acuity (BCDVA)
Day 15 (FU) vs Day-1
|
2 units on a scale
Standard Deviation 2.5
|
2 units on a scale
Standard Deviation 1.0
|
-1 units on a scale
Standard Deviation 2.9
|
2 units on a scale
Standard Deviation 4.0
|
2 units on a scale
Standard Deviation 1.9
|
0 units on a scale
Standard Deviation 2.3
|
0 units on a scale
Standard Deviation 3.2
|
1 units on a scale
Standard Deviation 2.4
|
1 units on a scale
Standard Deviation 2.4
|
2 units on a scale
Standard Deviation 3.7
|
0 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Day -1, Day 1, Day 5, Day 15 (FU)Population: Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.
Tear film break-up time was assessed by slit lamp examination (SLE). The shorter is the tear film break-up time, the worse is the dry eye symptom severity. The study includes Part 0, Part A and Part B. In Part B this endpoint was evaluated on days -1, 1, 5, 15 (FU). Follow up (FU) refers to participants' last available assessment.
Outcome measures
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Mean Tear Film Break up Time (TFBUT)
Day 1 vs Day -1
|
1.7 seconds
Standard Deviation 1.89
|
0.0 seconds
Standard Deviation 0.5
|
-2.6 seconds
Standard Deviation 2.95
|
0.4 seconds
Standard Deviation 0.86
|
-0.5 seconds
Standard Deviation 0.64
|
-0.4 seconds
Standard Deviation 1.93
|
0.0 seconds
Standard Deviation 0.67
|
0.5 seconds
Standard Deviation 1.14
|
0.4 seconds
Standard Deviation 0.96
|
0.1 seconds
Standard Deviation 1.11
|
0.2 seconds
Standard Deviation 0.79
|
|
Change in Mean Tear Film Break up Time (TFBUT)
Day 5 vs Day -1
|
-1.2 seconds
Standard Deviation 1.62
|
-0.3 seconds
Standard Deviation 1.04
|
0.9 seconds
Standard Deviation 1.21
|
0.1 seconds
Standard Deviation 0.69
|
-0.1 seconds
Standard Deviation 0.85
|
0.0 seconds
Standard Deviation 1.64
|
-0.7 seconds
Standard Deviation 1.53
|
-0.2 seconds
Standard Deviation 1.76
|
-0.4 seconds
Standard Deviation 1.52
|
0.2 seconds
Standard Deviation 2.03
|
-0.2 seconds
Standard Deviation 1.03
|
|
Change in Mean Tear Film Break up Time (TFBUT)
Day 15 (FU) vs Day -1
|
-1.4 seconds
Standard Deviation 1.65
|
0.2 seconds
Standard Deviation 0.29
|
-0.9 seconds
Standard Deviation 1.4
|
-0.1 seconds
Standard Deviation 1.32
|
0.4 seconds
Standard Deviation 0.77
|
-0.6 seconds
Standard Deviation 0.69
|
1.0 seconds
Standard Deviation 1.22
|
0.1 seconds
Standard Deviation 1.07
|
-0.4 seconds
Standard Deviation 1.83
|
-0 seconds
Standard Deviation 1.48
|
0.0 seconds
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Day -1, Day 1, Day 5, Day 15 (FU)Population: Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.
Slit lamp examination was used to assess the eyelid margin, conjunctiva, cornea, anterior chamber, iris and lens with the instillation of fluorescein to evaluate corneal fluorescein staining (modified Oxford scale). This is 7-point ordinal scale that scores 0, 0.5, and 1 to 5. On this scale the score 0 corresponds to no staining dots (complete corneal clearing) and the score 0.5 corresponds to three or less staining dots. The higher is the number of dots, the higher and worse is the score. The study includes Part 0, Part A and Part B. In Part B the endpoint was evaluated on days -1, 1, 5, 15 (FU).
Outcome measures
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Mean Corneal Fluorescein Staining
Day 1 vs Day -1
|
1.7 Units on a scale
Standard Deviation 1.89
|
0.0 Units on a scale
Standard Deviation 0.50
|
-2.6 Units on a scale
Standard Deviation 2.95
|
0.4 Units on a scale
Standard Deviation 0.86
|
-0.5 Units on a scale
Standard Deviation 0.64
|
-0.4 Units on a scale
Standard Deviation 1.93
|
0.0 Units on a scale
Standard Deviation 0.67
|
0.2 Units on a scale
Standard Deviation 1.14
|
0.4 Units on a scale
Standard Deviation 0.96
|
0.1 Units on a scale
Standard Deviation 1.11
|
0.2 Units on a scale
Standard Deviation 0.79
|
|
Change in Mean Corneal Fluorescein Staining
Day 5 vs Day -1
|
-1.2 Units on a scale
Standard Deviation 1.62
|
-0.3 Units on a scale
Standard Deviation 1.04
|
-0.9 Units on a scale
Standard Deviation 1.21
|
0.1 Units on a scale
Standard Deviation 0.69
|
-0.1 Units on a scale
Standard Deviation 0.85
|
0.0 Units on a scale
Standard Deviation 1.64
|
-0.7 Units on a scale
Standard Deviation 1.53
|
-0.2 Units on a scale
Standard Deviation 1.76
|
-0.4 Units on a scale
Standard Deviation 1.52
|
-0.2 Units on a scale
Standard Deviation 2.03
|
-0.2 Units on a scale
Standard Deviation 1.03
|
|
Change in Mean Corneal Fluorescein Staining
Day 15 (FU) vs Day -1
|
-1.4 Units on a scale
Standard Deviation 1.65
|
0.2 Units on a scale
Standard Deviation 0.29
|
-0.9 Units on a scale
Standard Deviation 1.40
|
-0.1 Units on a scale
Standard Deviation 1.32
|
0.4 Units on a scale
Standard Deviation 0.77
|
-0.6 Units on a scale
Standard Deviation 0.69
|
1.0 Units on a scale
Standard Deviation 1.22
|
0.1 Units on a scale
Standard Deviation 1.07
|
-0.4 Units on a scale
Standard Deviation 1.83
|
-0.0 Units on a scale
Standard Deviation 1.48
|
0.0 Units on a scale
Standard Deviation 1.08
|
PRIMARY outcome
Timeframe: Screening, Day 7, Day 15 (FU)Population: Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.
Intraocular pressure was determined using Goldmann applanation tonometry. The study includes Part 0, Part A and Part B. In Part B this endpoint was evaluated at screening and on days 7, 15 (FU). Follow up (FU) refers to participants' last available assessment.
Outcome measures
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Intraocular Pressure (IOP)
Day 15 (FU) vs screening
|
-1 mmHg
Standard Deviation 2.5
|
1 mmHg
Standard Deviation 0.6
|
-1 mmHg
Standard Deviation 1.0
|
1 mmHg
Standard Deviation 2.7
|
-1 mmHg
Standard Deviation 3.3
|
1 mmHg
Standard Deviation 3.2
|
-2 mmHg
Standard Deviation 2.8
|
0 mmHg
Standard Deviation 5.3
|
-1 mmHg
Standard Deviation 3.3
|
-1 mmHg
Standard Deviation 3.1
|
-3 mmHg
Standard Deviation 3.4
|
|
Change in Intraocular Pressure (IOP)
Day 7 vs screening
|
1 mmHg
Standard Deviation 2.0
|
-1 mmHg
Standard Deviation 1.5
|
-1 mmHg
Standard Deviation 2.6
|
1 mmHg
Standard Deviation 1.8
|
1 mmHg
Standard Deviation 3.9
|
1 mmHg
Standard Deviation 1.6
|
-2 mmHg
Standard Deviation 1.8
|
-1 mmHg
Standard Deviation 2.0
|
0 mmHg
Standard Deviation 3
|
-2 mmHg
Standard Deviation 3.7
|
-2 mmHg
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Part B - Day 7Population: Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.
Dilated fundus ophthalmoscopy (DFO) is used to view the eye's interior, allowing assessment of the retina/macula/choroid, optic nerve head, blood vessels, and other features. The outcome can be normal or abnormal. The study includes Part 0, Part A and Part B. In Part B this endpoint was evaluated on day 7.
Outcome measures
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 Participants
1 x 35 µL drop 3 subjects rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 Participants
3 x 35 µL drops applied at 4 h intervals 6 subjects Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 Participants
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Abnormal Findings in Dilated Fundus Ophthalmoscopy
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
0 percentage of abnormal findings
Standard Deviation 0
|
Adverse Events
rhNGF 0.5 µg/mL Sentinel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
rhNGF 5 µg/mL Sentinel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
rhNGF 20 µg/mL Sentinel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
rhNGF 20 µg/mL Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
rhNGF 60 µg/mL Part A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
rhNGF 180 µg/mL Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Part A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
rhNGF 20 µg/mL Part B
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
rhNGF 60 µg/mL Part B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
rhNGF 180 µg/mL Part B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Part B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rhNGF 0.5 µg/mL Sentinel
n=3 participants at risk
1 x 35 µL drop 3 subjects
rhNGF 0.5 µg/mL Sentinel: one drop administration
|
rhNGF 5 µg/mL Sentinel
n=3 participants at risk
1 x 35 µL drop 3 subjects
rhNGF 5 µg/mL Sentinel
|
rhNGF 20 µg/mL Sentinel
n=3 participants at risk
1 x 35 µL drop 3 subjects
rhNGF 20 µg/mL Sentinel
|
rhNGF 20 µg/mL Part A
n=6 participants at risk
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 20 µg/mL Part A
|
rhNGF 60 µg/mL Part A
n=6 participants at risk
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 60 µg/mL Part A
|
rhNGF 180 µg/mL Part A
n=7 participants at risk
3 x 35 µL drops applied at 4 h intervals 6 subjects
rhNGF 180 µg/mL Part A
|
Placebo Part A
n=6 participants at risk
3 x 35 µL drops applied at 4 h intervals 6 subjects
Placebo Part A
|
rhNGF 20 µg/mL Part B
n=12 participants at risk
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 12 subject
rhNGF 20 µg/mL Part B
|
rhNGF 60 µg/mL Part B
n=9 participants at risk
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 60 µg/mL Part B
|
rhNGF 180 µg/mL Part B
n=9 participants at risk
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 9 subjects
rhNGF 180 µg/mL Part B
|
Placebo Part B
n=10 participants at risk
3 x 35 µL drops applied at 4 h intervals per day during 5 consecutive days 10 subjects
Placebo Part B
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Abnormals sensation in eye
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Eye irritation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Photophobia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Eye pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
22.2%
2/9 • Number of events 2
|
55.6%
5/9 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
|
Eye disorders
Eye discharge
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Eye pruritus
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Eye swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Eye disorders
Visual impairment
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Catheter site related reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Investigations
Corneal staining
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Orapharyngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/10
|
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