Trial Outcomes & Findings for Piiloset Trehalose Emulsion Eye Drop Study in Moderate or Severe Dry Eye (NCT NCT03569202)
NCT ID: NCT03569202
Last Updated: 2019-12-13
Results Overview
Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
From baseline to Day 30 (Part 3)
Results posted on
2019-12-13
Participant Flow
The study comprised three sequential parts. Parts 1 to 3 involved different participants each, thus no participant flow between parts (or periods) took place.
Unit of analysis: Eyes
Participant milestones
| Measure |
Emulsion Eye Drops
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Piiloset Trehalose Emulsion Eye Drops: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops
* Part 1: on one eye 4 times during one day
* Part 2: on one randomized eye 3 times a day for 10 days
* Part 3: on both eyes 3 times a day for 30 days
|
Control Eye Drops
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Control Eye Drops: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops
* Part 1: not used
* Part 2: on randomized contralateral eye 3 times a day for 10 days
* Part 3: on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Part 1
STARTED
|
3 3
|
0 0
|
|
Part 1
COMPLETED
|
3 3
|
0 0
|
|
Part 1
NOT COMPLETED
|
0 0
|
0 0
|
|
Part 2
STARTED
|
9 9
|
9 9
|
|
Part 2
COMPLETED
|
9 9
|
9 9
|
|
Part 2
NOT COMPLETED
|
0 0
|
0 0
|
|
Part 3
STARTED
|
26 0
|
26 0
|
|
Part 3
COMPLETED
|
24 0
|
25 0
|
|
Part 3
NOT COMPLETED
|
2 0
|
1 0
|
Reasons for withdrawal
| Measure |
Emulsion Eye Drops
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Piiloset Trehalose Emulsion Eye Drops: Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops
* Part 1: on one eye 4 times during one day
* Part 2: on one randomized eye 3 times a day for 10 days
* Part 3: on both eyes 3 times a day for 30 days
|
Control Eye Drops
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Control Eye Drops: Topical application of preservative-free multidose Hyaluronic Acid Eye Drops
* Part 1: not used
* Part 2: on randomized contralateral eye 3 times a day for 10 days
* Part 3: on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Part 3
Physician Decision
|
1
|
0
|
|
Part 3
Other
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 13.8 • n=26 Participants
|
51.5 years
STANDARD_DEVIATION 11.4 • n=26 Participants
|
53.3 years
STANDARD_DEVIATION 12.6 • n=52 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=26 Participants
|
18 Participants
n=26 Participants
|
36 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=26 Participants
|
8 Participants
n=26 Participants
|
16 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Finland
|
26 participants
n=26 Participants
|
26 participants
n=26 Participants
|
52 participants
n=52 Participants
|
|
Body Weight
|
75.1 kg
STANDARD_DEVIATION 11.7 • n=26 Participants
|
76.9 kg
STANDARD_DEVIATION 15.8 • n=26 Participants
|
76.0 kg
STANDARD_DEVIATION 13.8 • n=52 Participants
|
|
Ocular Surface Disease Index (OSDI)
|
48.1 units on a scale
STANDARD_DEVIATION 10.8 • n=26 Participants
|
45.6 units on a scale
STANDARD_DEVIATION 11.3 • n=26 Participants
|
46.9 units on a scale
STANDARD_DEVIATION 11.0 • n=52 Participants
|
|
Tear Break-Up Time (TBUT)
|
3.35 s
STANDARD_DEVIATION 2.62 • n=26 Participants
|
3.46 s
STANDARD_DEVIATION 2.04 • n=26 Participants
|
3.40 s
STANDARD_DEVIATION 2.33 • n=52 Participants
|
|
Tear osmolarity
|
304.0 mOsm/L
STANDARD_DEVIATION 11.8 • n=26 Participants
|
307.3 mOsm/L
STANDARD_DEVIATION 12.4 • n=26 Participants
|
305.6 mOsm/L
STANDARD_DEVIATION 12.1 • n=52 Participants
|
|
Blink rate
|
18.17 Blinks/min
STANDARD_DEVIATION 11.49 • n=26 Participants
|
22.27 Blinks/min
STANDARD_DEVIATION 12.93 • n=26 Participants
|
20.22 Blinks/min
STANDARD_DEVIATION 12.28 • n=52 Participants
|
|
Ocular protection index (OPI)
|
0.98 ratio
STANDARD_DEVIATION 0.937 • n=26 Participants
|
1.23 ratio
STANDARD_DEVIATION 1.188 • n=26 Participants
|
1.11 ratio
STANDARD_DEVIATION 1.067 • n=52 Participants
|
|
Corneal staining
|
1.37 score on a scale
STANDARD_DEVIATION 0.794 • n=26 Participants
|
1.21 score on a scale
STANDARD_DEVIATION 0.603 • n=26 Participants
|
1.29 score on a scale
STANDARD_DEVIATION 0.703 • n=52 Participants
|
|
Conjunctival staining (temporal)
|
1.06 score on a scale
STANDARD_DEVIATION 0.432 • n=26 Participants
|
1.06 score on a scale
STANDARD_DEVIATION 0.497 • n=26 Participants
|
1.06 score on a scale
STANDARD_DEVIATION 0.461 • n=52 Participants
|
|
Conjunctival staining (nasal)
|
1.23 score on a scale
STANDARD_DEVIATION 0.430 • n=26 Participants
|
1.23 score on a scale
STANDARD_DEVIATION 0.406 • n=26 Participants
|
1.23 score on a scale
STANDARD_DEVIATION 0.414 • n=52 Participants
|
|
Conjunctival redness
|
1.98 score on a scale
STANDARD_DEVIATION 0.685 • n=26 Participants
|
1.94 score on a scale
STANDARD_DEVIATION 0.829 • n=26 Participants
|
1.96 score on a scale
STANDARD_DEVIATION 0.753 • n=52 Participants
|
|
Lid redness
|
1.29 score on a scale
STANDARD_DEVIATION 0.751 • n=26 Participants
|
1.29 score on a scale
STANDARD_DEVIATION 0.724 • n=26 Participants
|
1.29 score on a scale
STANDARD_DEVIATION 0.730 • n=52 Participants
|
|
Intraocular pressure
|
14.92 mmHg (Goldmann tonometer)
STANDARD_DEVIATION 2.134 • n=26 Participants
|
15.69 mmHg (Goldmann tonometer)
STANDARD_DEVIATION 2.558 • n=26 Participants
|
15.31 mmHg (Goldmann tonometer)
STANDARD_DEVIATION 2.364 • n=52 Participants
|
|
Ocular surgery, trauma, refractive laser vision correction
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Eye infection
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Allergy
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
|
Current or planned pregnancy and nursing
|
0 Participants
n=26 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Intent-to-treat (ITT) dataset
Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline OSDI
|
-24.64 units on a scale
Standard Deviation 16.186
|
-26.53 units on a scale
Standard Deviation 14.620
|
PRIMARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Intent-to-treat (ITT) dataset
Instrumental assay of tear fluid osmolarity (mOsm/L)
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Tear Osmolarity
|
-4.75 mOsm/L
Standard Deviation 16.224
|
-1.77 mOsm/L
Standard Deviation 21.531
|
PRIMARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Intent-to-treat (ITT) dataset
Tear film break-up time (TBUT) (s)
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline TBUT
|
1.71 s
Standard Deviation 3.424
|
0.87 s
Standard Deviation 1.809
|
SECONDARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Intent-to-treat (ITT) dataset
Measurement of spontaneous eyelid blinks per minute
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Blink Rate
|
0.02 Blinks/min
Standard Deviation 8.721
|
-2.15 Blinks/min
Standard Deviation 10.161
|
SECONDARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Intent-to-treat (ITT) dataset
OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value \>1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles.
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Ocular Protection Index (OPI)
|
0.56 ratio
Standard Deviation 1.078
|
0.05 ratio
Standard Deviation 0.680
|
SECONDARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Per-protocol (PP) dataset
Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.
Outcome measures
| Measure |
Emulsion Eye Drops
n=24 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=25 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Corneal Staining
|
-0.38 score on a scale
Standard Deviation 0.695
|
-0.22 score on a scale
Standard Deviation 0.522
|
SECONDARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Per-protocol (PP) dataset
Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.
Outcome measures
| Measure |
Emulsion Eye Drops
n=24 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=25 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Conjunctival (Temporal) Staining
|
-0.19 score on a scale
Standard Deviation 0.507
|
-0.02 score on a scale
Standard Deviation 0.810
|
SECONDARY outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Per-protocol (PP) dataset
Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.
Outcome measures
| Measure |
Emulsion Eye Drops
n=24 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=25 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Conjunctival (Nasal) Staining
|
-0.27 score on a scale
Standard Deviation 0.608
|
-0.12 score on a scale
Standard Deviation 0.666
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Safety dataset
Best corrected visual acuity (ETDRS charts 1 \& 2, 2000 series)
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Visual Acuity
|
-0.03 logMAR chart log units
Standard Deviation 0.071
|
-0.04 logMAR chart log units
Standard Deviation 0.080
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Safety dataset
Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Conjunctival Redness
|
-0.46 score on a scale
Standard Deviation 0.647
|
-0.27 score on a scale
Standard Deviation 0.652
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Safety dataset
Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale): 0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness.
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Lid Redness
|
-0.37 score on a scale
Standard Deviation 0.672
|
-0.19 score on a scale
Standard Deviation 0.549
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Day 30 (Part 3)Population: Safety dataset
Intraocular pressure measured using Goldmann applanation tonometry (mmHg)
Outcome measures
| Measure |
Emulsion Eye Drops
n=26 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=26 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Intraocular Pressure
|
-0.12 mmHg
Standard Deviation 1.705
|
-0.42 mmHg
Standard Deviation 1.653
|
POST_HOC outcome
Timeframe: From baseline to Day 30 (Part 3)Population: ITT population with hyperosmolar tears (mean of eyes ≥308 mOsm/L)
Instrumental assay of tear fluid osmolarity (mOsm/L) in a hyperosmolar subgroup of participants (mean of eyes ≥308 mOsm/L)
Outcome measures
| Measure |
Emulsion Eye Drops
n=8 Participants
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Results are reported for Part 3 only:
Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops on both eyes 3 times a day for 30 days
|
Control Eye Drops
n=14 Participants
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Results are reported for Part 3 only:
Topical application of preservative-free multidose Hyaluronic Acid Eye Drops on both eyes 3 times a day for 30 days
|
|---|---|---|
|
Change From Baseline Tear Osmolarity in Hyperosmolar Participants
|
-17.06 mOsm/L
Standard Deviation 10.425
|
-15.07 mOsm/L
Standard Deviation 16.596
|
Adverse Events
Emulsion Eye Drops
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Eye Drops
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Emulsion Eye Drops
n=38 participants at risk
Daily treatment with Piiloset Trehalose Emulsion Eye Drops
Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Piiloset Trehalose Emulsion Eye Drops at least once and from whom at least one safety measurement was obtained after randomization.
|
Control Eye Drops
n=35 participants at risk
Daily treatment with Hyaluronic Acid Eye Drops (a CE-marked medical device)
Adverse events are reported for the safety population in all parts of the study, including all randomized subjects who received Hyaluronic Acid Eye Drops at least once and from whom at least one safety measurement was obtained after randomization.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
AE (adverse event)
|
2.6%
1/38 • Number of events 1 • Part 1: 1 day; Part 2: 10 days; Part 3: 30 days
ADE (adverse device effect); AE (adverse event); SADE (serious adverse device effect); SAE (serious adverse event); USADE (unanticipated serious adverse device effect) Total Number of Participants at Risk (safety population); Emulsion Eye Drops: 3 + 9 + 26 = 38 participants; Control Eye Drops: 0 + 9 + 26 = 35 participants. Adverse events were collected throughout the study during visits to study site, in study diaries, and from direct contacts to study personnel between visits.
|
0.00%
0/35 • Part 1: 1 day; Part 2: 10 days; Part 3: 30 days
ADE (adverse device effect); AE (adverse event); SADE (serious adverse device effect); SAE (serious adverse event); USADE (unanticipated serious adverse device effect) Total Number of Participants at Risk (safety population); Emulsion Eye Drops: 3 + 9 + 26 = 38 participants; Control Eye Drops: 0 + 9 + 26 = 35 participants. Adverse events were collected throughout the study during visits to study site, in study diaries, and from direct contacts to study personnel between visits.
|
Additional Information
Dr. Jarmo Laihia, Manager of Clinical & Formulation Development
Finnsusp Ltd.
Phone: 358 50 377 1212
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restrictions on the PI are that the sponsor can review results communications 30 days prior to planned date of public release. If public release of information in communications may jeopardize protecting sponsor's immaterial rights, the sponsor can additionally embargo the communications for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER