Trial Outcomes & Findings for Pharmacodynamics of a Fixed Dose Combination of 0.34% Tropicamide and 2.5% Phenylephrine Hydrochloride, Eye Drop, Solution (NCT NCT07075224)
NCT ID: NCT07075224
Last Updated: 2026-06-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
60 minutes
Results posted on
2026-06-17
Participant Flow
Participant milestones
| Measure |
Mydriasert® Insert First, Then IMP 08P2002F0
First Intervention (6 hours of follow-up):1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation.
|
IMP 08P2002F0 First, Then Mydriasert(r)
First Intervention (6 hours of follow-up):1 eye drop. Rinsing will be performed with NaCl 30 min after instillation. Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
10
|
10
|
|
Period 2
COMPLETED
|
10
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=20 Participants
All Study Participants
|
|---|---|
|
Age, Continuous
|
42.75 years
STANDARD_DEVIATION 15.341 • n=20 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: Only 1 eye (the randomized eye) is measured per participant.
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Change in Pupil Diameter at 60 Minutes From the Time of First Dose Versus Baseline, as Measured With Photo (Central Reading)
|
3.28 millimeter
Standard Deviation 0.95
|
3.29 millimeter
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 6 hours post dosePopulation: Only 1 eye (the randomized eye) is measured per participant.
This endpoint represents the time to first achievement of a pupil diameter ≥7.0 mm, analyzed using Kaplan-Meier time-to-event methods. The reported median time corresponds to the time at which 50% of eyes reached this threshold and does not indicate that all eyes had achieved a pupil diameter ≥7.0 mm at that timepoint. While all eyes eventually reached ≥7.0 mm during the observation period (no censored observations), some did so after the 30-minute assessment reported in Outcome Measure 8.
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Time to Obtain Sufficient Mydriasis
|
20 minutes
95% Confidence Interval 0 • Interval 17.37 to 22.63
|
30 minutes
95% Confidence Interval 0 • Interval 23.15 to 36.85
|
SECONDARY outcome
Timeframe: Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.Population: Only 1 eye (the randomized eye) is measured per participant.
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Proportion of Eyes Achieving Pupil Diameter of 6.0 mm or Greater
at 30 minutes
|
20 eye
|
19 eye
|
|
Proportion of Eyes Achieving Pupil Diameter of 6.0 mm or Greater
at 1 hour
|
20 eye
|
20 eye
|
|
Proportion of Eyes Achieving Pupil Diameter of 6.0 mm or Greater
at 2 hour
|
20 eye
|
20 eye
|
|
Proportion of Eyes Achieving Pupil Diameter of 6.0 mm or Greater
Throughout the 6 hours
|
20 eye
|
20 eye
|
SECONDARY outcome
Timeframe: Throughout the 6 hours, at 30 minutes, at 1 hour and 2 hours.Population: Only 1 eye (the randomized eye) is measured per participant.
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Proportion of Eyes Achieving Pupil Diameter of 7.0 mm
at 30 minutes
|
20 eye
|
10 eye
|
|
Proportion of Eyes Achieving Pupil Diameter of 7.0 mm
at 1 hour
|
20 eye
|
20 eye
|
|
Proportion of Eyes Achieving Pupil Diameter of 7.0 mm
at 2 hour
|
20 eye
|
20 eye
|
|
Proportion of Eyes Achieving Pupil Diameter of 7.0 mm
Throughout the 6 hours
|
20 eye
|
20 eye
|
SECONDARY outcome
Timeframe: 6 hours post dosePopulation: Only 1 eye (the randomized eye) is measured per participant.
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Time From Baseline to Maximal Pupil Dilation
|
60 minutes
Interval 47.118 to 72.882
|
90 minutes
Interval 84.523 to 95.477
|
SECONDARY outcome
Timeframe: At 10 minutes, 20 minutes, 30 minutes, 45 minutes, 60 minutes, 1 hour and 15 minutes, 1 hour and 30 minutes, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 4 hours and 30 minutes, 5 hours, 6 hours.Population: 1 eye (the randomized one) is measured per participant
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Change in Pupil Diameter at Other Timepoints
at 1h30
|
3.27 millimeter
Standard Deviation 0.93
|
3.65 millimeter
Standard Deviation 0.84
|
|
Change in Pupil Diameter at Other Timepoints
at 2h
|
3.14 millimeter
Standard Deviation 0.98
|
3.64 millimeter
Standard Deviation 0.88
|
|
Change in Pupil Diameter at Other Timepoints
At 2h30
|
2.92 millimeter
Standard Deviation 1.03
|
3.61 millimeter
Standard Deviation 0.86
|
|
Change in Pupil Diameter at Other Timepoints
at 3h
|
2.65 millimeter
Standard Deviation 1.08
|
3.48 millimeter
Standard Deviation 0.88
|
|
Change in Pupil Diameter at Other Timepoints
3 h 30 min
|
2.42 millimeter
Standard Deviation 1.10
|
3.34 millimeter
Standard Deviation 0.94
|
|
Change in Pupil Diameter at Other Timepoints
at 4h
|
2.20 millimeter
Standard Deviation 1.03
|
3.18 millimeter
Standard Deviation 0.96
|
|
Change in Pupil Diameter at Other Timepoints
at 4h30
|
1.92 millimeter
Standard Deviation 1.04
|
2.90 millimeter
Standard Deviation 1.07
|
|
Change in Pupil Diameter at Other Timepoints
at 5h
|
1.73 millimeter
Standard Deviation 0.92
|
2.48 millimeter
Standard Deviation 1.17
|
|
Change in Pupil Diameter at Other Timepoints
at 6h
|
1.25 millimeter
Standard Deviation 0.96
|
2.00 millimeter
Standard Deviation 1.01
|
|
Change in Pupil Diameter at Other Timepoints
at 60 min
|
3.28 millimeter
Standard Deviation 0.95
|
3.29 millimeter
Standard Deviation 0.81
|
|
Change in Pupil Diameter at Other Timepoints
at 30 minutes
|
2.88 millimeter
Standard Deviation 0.90
|
1.57 millimeter
Standard Deviation 1.10
|
|
Change in Pupil Diameter at Other Timepoints
at 45 minutes
|
3.18 millimeter
Standard Deviation 0.91
|
2.70 millimeter
Standard Deviation 0.94
|
|
Change in Pupil Diameter at Other Timepoints
at 1h15
|
3.31 millimeter
Standard Deviation 0.96
|
3.51 millimeter
Standard Deviation 0.84
|
|
Change in Pupil Diameter at Other Timepoints
at 10 minutes
|
1.43 millimeter
Standard Deviation 0.79
|
0 millimeter
Standard Deviation 0.31
|
|
Change in Pupil Diameter at Other Timepoints
at 20 minutes
|
2.40 millimeter
Standard Deviation 0.82
|
0.38 millimeter
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: At baseline, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 60 minutes, 1 hour and 15 minutes, 1 hour and 30 minutes, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 4 hours and 30 minutes, 5 hours, 6 hours.Population: 1 eye (the randomized one) is measured per participant
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Pupil Size
Baseline
|
5.37 millimeter
Standard Deviation 0.76
|
5.37 millimeter
Standard Deviation 0.95
|
|
Pupil Size
at 10 min
|
6.80 millimeter
Standard Deviation 0.73
|
5.36 millimeter
Standard Deviation 0.98
|
|
Pupil Size
at 20 min
|
7.76 millimeter
Standard Deviation 0.58
|
5.75 millimeter
Standard Deviation 0.97
|
|
Pupil Size
at 30 min
|
8.24 millimeter
Standard Deviation 0.64
|
6.94 millimeter
Standard Deviation 0.94
|
|
Pupil Size
At 45 min
|
8.55 millimeter
Standard Deviation 0.66
|
8.07 millimeter
Standard Deviation 0.92
|
|
Pupil Size
At 60 min
|
8.65 millimeter
Standard Deviation 0.68
|
8.66 millimeter
Standard Deviation 0.65
|
|
Pupil Size
at 1h15 min
|
8.67 millimeter
Standard Deviation 0.67
|
8.88 millimeter
Standard Deviation 0.64
|
|
Pupil Size
At 2h
|
8.51 millimeter
Standard Deviation 0.66
|
9.01 millimeter
Standard Deviation 0.63
|
|
Pupil Size
At 2h30
|
8.28 millimeter
Standard Deviation 0.69
|
8.98 millimeter
Standard Deviation 0.63
|
|
Pupil Size
at 3h00
|
8.02 millimeter
Standard Deviation 0.75
|
8.84 millimeter
Standard Deviation 0.72
|
|
Pupil Size
At 3h30
|
7.78 millimeter
Standard Deviation 0.75
|
8.71 millimeter
Standard Deviation 0.83
|
|
Pupil Size
At 4h
|
7.56 millimeter
Standard Deviation 0.77
|
8.54 millimeter
Standard Deviation 0.90
|
|
Pupil Size
At 4h30
|
7.29 millimeter
Standard Deviation 0.75
|
8.27 millimeter
Standard Deviation 1.00
|
|
Pupil Size
At 5h00
|
7.10 millimeter
Standard Deviation 0.75
|
7.85 millimeter
Standard Deviation 1.14
|
|
Pupil Size
At 6h00
|
6.62 millimeter
Standard Deviation 0.85
|
7.37 millimeter
Standard Deviation 1.13
|
|
Pupil Size
at 1h30
|
8.64 millimeter
Standard Deviation 0.65
|
9.02 millimeter
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: At 10 minutes, 20 minutes, 30 minutes, 45 minutes, 60 minutes, 1 hour and 15 minutes, 1 hour and 30 minutes, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 4 hours and 30 minutes, 5 hours, 6 hoursPopulation: 1 eye (the randomized one) is measured per participant
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Distribution of Pupil Diameters
at 10 minutes
|
6.700 millimeter
Interval 5.4 to 8.1
|
5.350 millimeter
Interval 3.6 to 7.0
|
|
Distribution of Pupil Diameters
at 20 minutes
|
7.600 millimeter
Interval 6.8 to 9.2
|
5.880 millimeter
Interval 4.25 to 7.3
|
|
Distribution of Pupil Diameters
at 30 minutes
|
8.215 millimeter
Interval 7.29 to 9.7
|
6.950 millimeter
Interval 5.3 to 8.98
|
|
Distribution of Pupil Diameters
at 45 minutes
|
8.500 millimeter
Interval 7.62 to 9.8
|
8.000 millimeter
Interval 5.9 to 9.81
|
|
Distribution of Pupil Diameters
at 60 minutes
|
8.650 millimeter
Interval 7.64 to 9.8
|
8.600 millimeter
Interval 7.4 to 9.91
|
|
Distribution of Pupil Diameters
at 1h15
|
8.520 millimeter
Interval 7.68 to 9.94
|
8.900 millimeter
Interval 7.89 to 10.23
|
|
Distribution of Pupil Diameters
at 1h30
|
8.540 millimeter
Interval 7.6 to 9.82
|
9.050 millimeter
Interval 8.07 to 10.16
|
|
Distribution of Pupil Diameters
At 2h
|
8.470 millimeter
Interval 7.6 to 9.9
|
9.100 millimeter
Interval 7.8 to 10.07
|
|
Distribution of Pupil Diameters
at 2h30
|
8.200 millimeter
Interval 7.3 to 9.9
|
9.100 millimeter
Interval 7.79 to 10.1
|
|
Distribution of Pupil Diameters
at 3h
|
7.950 millimeter
Interval 6.8 to 9.9
|
8.845 millimeter
Interval 7.19 to 10.0
|
|
Distribution of Pupil Diameters
At 3h30
|
7.475 millimeter
Interval 6.9 to 9.6
|
8.700 millimeter
Interval 6.62 to 9.9
|
|
Distribution of Pupil Diameters
At 4h00
|
7.400 millimeter
Interval 6.6 to 9.3
|
8.700 millimeter
Interval 6.04 to 9.9
|
|
Distribution of Pupil Diameters
at 4h30
|
7.100 millimeter
Interval 6.3 to 8.9
|
8.300 millimeter
Interval 5.47 to 9.6
|
|
Distribution of Pupil Diameters
at 5h
|
6.950 millimeter
Interval 6.0 to 8.8
|
7.980 millimeter
Interval 5.3 to 9.7
|
|
Distribution of Pupil Diameters
at 6h
|
6.550 millimeter
Interval 5.2 to 8.3
|
7.550 millimeter
Interval 5.19 to 9.1
|
SECONDARY outcome
Timeframe: At 10 minutes, 30 minutes, 60 minutes, 1 hour and 30 minutes, 2 hours, and 6 hours post-administration.Healthy volunteers will be asked to respond regarding the following ocular signs after instillation of the respective IMP: irritation/burning/stinging, eye dryness, foreign body sensation, blurred vision by "yes" or "no" and to assess the severity by grading 0 = none, 1 = slight, 2 = moderate, 3 = severe, if sign(s) were noted with "yes" A higher score means a worse result.
Outcome measures
| Measure |
Mydriasert® Insert
n=20 Participants
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 Participants
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 10 min · None
|
17 Participants
|
16 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 10 min · Slight
|
3 Participants
|
4 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 10 min · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 10 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 30 min · None
|
19 Participants
|
16 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 30 min · Slight
|
1 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 30 min · Moderate
|
0 Participants
|
3 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 30 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 60 min · None
|
18 Participants
|
14 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 60 min · Slight
|
2 Participants
|
4 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 60 min · Moderate
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 60 min · Severe
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 2h · None
|
20 Participants
|
17 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 2h · Slight
|
0 Participants
|
3 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 2h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 2h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 6h · None
|
20 Participants
|
20 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 6h · Slight
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 6h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Irritation/Burning/stinging : 6h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation 10 min · None
|
19 Participants
|
8 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation 10 min · Slight
|
1 Participants
|
9 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation 10 min · Moderate
|
0 Participants
|
3 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation 10 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 30 min · None
|
20 Participants
|
10 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 30 min · Slight
|
0 Participants
|
7 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 30 min · Moderate
|
0 Participants
|
2 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 30 min · Severe
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 60 min · None
|
19 Participants
|
13 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 60 min · Slight
|
1 Participants
|
5 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 60 min · Moderate
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 60 min · Severe
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 2h · None
|
19 Participants
|
18 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 2h · Slight
|
1 Participants
|
2 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 2h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 2h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 6h · None
|
20 Participants
|
19 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 6h · Slight
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 6h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Foreign body sensation : 6h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 10 min · None
|
6 Participants
|
20 Participants
|
|
Subject Ocular Discomfort
Blurred vision 10 min · Slight
|
10 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 10 min · Moderate
|
4 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 10 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 30 min · None
|
1 Participants
|
9 Participants
|
|
Subject Ocular Discomfort
Blurred vision 30 min · Slight
|
9 Participants
|
7 Participants
|
|
Subject Ocular Discomfort
Blurred vision 30 min · Moderate
|
8 Participants
|
4 Participants
|
|
Subject Ocular Discomfort
Blurred vision 30 min · Severe
|
2 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 60 min · None
|
2 Participants
|
4 Participants
|
|
Subject Ocular Discomfort
Blurred vision 60 min · Slight
|
9 Participants
|
7 Participants
|
|
Subject Ocular Discomfort
Blurred vision 60 min · Moderate
|
7 Participants
|
9 Participants
|
|
Subject Ocular Discomfort
Blurred vision 60 min · Severe
|
2 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 2h · None
|
5 Participants
|
4 Participants
|
|
Subject Ocular Discomfort
Blurred vision 2h · Slight
|
13 Participants
|
13 Participants
|
|
Subject Ocular Discomfort
Blurred vision 2h · Moderate
|
2 Participants
|
3 Participants
|
|
Subject Ocular Discomfort
Blurred vision 2h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 6h · None
|
19 Participants
|
15 Participants
|
|
Subject Ocular Discomfort
Blurred vision 6h · Slight
|
1 Participants
|
5 Participants
|
|
Subject Ocular Discomfort
Blurred vision 6h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Blurred vision 6h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry eye 10 min · None
|
20 Participants
|
20 Participants
|
|
Subject Ocular Discomfort
Dry eye 10 min · Slight
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry eye 10 min · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry eye 10 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 30 min · None
|
20 Participants
|
19 Participants
|
|
Subject Ocular Discomfort
Dry Eye 30 min · Slight
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 30 min · Moderate
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Dry Eye 30 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 60 min · None
|
20 Participants
|
17 Participants
|
|
Subject Ocular Discomfort
Dry Eye 60 min · Slight
|
0 Participants
|
3 Participants
|
|
Subject Ocular Discomfort
Dry Eye 60 min · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 60 min · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 2h · None
|
20 Participants
|
20 Participants
|
|
Subject Ocular Discomfort
Dry Eye 2h · Slight
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 2h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 2h · Severe
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 6h · None
|
20 Participants
|
19 Participants
|
|
Subject Ocular Discomfort
Dry Eye 6h · Slight
|
0 Participants
|
1 Participants
|
|
Subject Ocular Discomfort
Dry Eye 6h · Moderate
|
0 Participants
|
0 Participants
|
|
Subject Ocular Discomfort
Dry Eye 6h · Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Throughout the 6 hours, at 3 hours, 4 hours, 5 hours, 6 hours.Population: 1 eye (randomized eye) analysed per participant
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
at 3h
|
0 eye
|
0 eye
|
|
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
at 4h
|
0 eye
|
0 eye
|
|
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
At 5h
|
0 eye
|
1 eye
|
|
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
at 6h
|
1 eye
|
0 eye
|
|
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
Throughout the 6 hours
|
1 eye
|
0 eye
|
SECONDARY outcome
Timeframe: Throughout the 6 hours, at 3 hours, 4 hours, 5 hours, 6 hours.Population: 1 eye analysed (randomized eye) per participant
Outcome measures
| Measure |
Mydriasert® Insert
n=20 eye
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 eye
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Percentage of Subjects' Study Eyes Returning to Less Than or Equal to 0.2 mm From Baseline Pupil Diameter
at 4h
|
0 eye
|
0 eye
|
|
Percentage of Subjects' Study Eyes Returning to Less Than or Equal to 0.2 mm From Baseline Pupil Diameter
at 5h
|
0 eye
|
1 eye
|
|
Percentage of Subjects' Study Eyes Returning to Less Than or Equal to 0.2 mm From Baseline Pupil Diameter
at 3h
|
0 eye
|
0 eye
|
|
Percentage of Subjects' Study Eyes Returning to Less Than or Equal to 0.2 mm From Baseline Pupil Diameter
at 6h
|
1 eye
|
1 eye
|
|
Percentage of Subjects' Study Eyes Returning to Less Than or Equal to 0.2 mm From Baseline Pupil Diameter
Throughout 6 h
|
1 eye
|
1 eye
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 10 post doseOutcome measures
| Measure |
Mydriasert® Insert
n=20 Participants
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
IMP 08P2002F0
n=20 Participants
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
|---|---|---|
|
Occurrence of Adverse Event
|
0 adverse event
|
1 adverse event
|
Adverse Events
IMP 08P2002F0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mydriasert® Insert
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IMP 08P2002F0
n=20 participants at risk
1 eye drop. Rinsing will be performed with NaCl 30 min after instillation
|
Mydriasert® Insert
n=20 participants at risk
1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min).
|
|---|---|---|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/20 • 12 days
|
5.0%
1/20 • 12 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Written approval from Sponsor
- Publication restrictions are in place
Restriction type: OTHER