Trial Outcomes & Findings for Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model (NCT NCT00689078)
NCT ID: NCT00689078
Last Updated: 2020-09-02
Results Overview
A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
3, 5, 7 minutes post-CAC
Results posted on
2020-09-02
Participant Flow
Subjects were recruited from one site in the US.
Participant flow and baseline characteristics are presented for the 36 subjects that met all inclusion and none of the exclusion criteria and were randomized to receive Pred Forte, Pred Mild, Alrex, or Tears Naturale. 36 subjects were enrolled, 4 discontinued, and 32 subjects completed the study.
Participant milestones
| Measure |
Pred Forte
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
Intent to Treat
|
9
|
7
|
8
|
8
|
|
Overall Study
COMPLETED
|
9
|
7
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Baseline characteristics by cohort
| Measure |
Pred Forte
n=9 Participants
Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
|
Pred Mild
n=9 Participants
Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
|
Alrex
n=9 Participants
Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
|
Tears Naturale (Placebo)
n=9 Participants
Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.11 years
STANDARD_DEVIATION 6.15 • n=5 Participants
|
44.11 years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
44.67 years
STANDARD_DEVIATION 18.65 • n=5 Participants
|
45.78 years
STANDARD_DEVIATION 14.71 • n=4 Participants
|
43.67 years
STANDARD_DEVIATION 13.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Full Analysis Set
A baseline CAC was performed on Day 0. Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Itching at Baseline (Day 0)
3 minutes post-CAC
|
2.53 units on a scale
Standard Deviation 0.507
|
3.08 units on a scale
Standard Deviation 0.771
|
2.61 units on a scale
Standard Deviation 0.953
|
2.5 units on a scale
Standard Deviation 0.781
|
|
Ocular Itching at Baseline (Day 0)
5 minutes post-CAC
|
2.92 units on a scale
Standard Deviation 0.661
|
3.47 units on a scale
Standard Deviation 0.475
|
3.06 units on a scale
Standard Deviation 0.682
|
2.75 units on a scale
Standard Deviation 0.612
|
|
Ocular Itching at Baseline (Day 0)
7 minutes post-CAC
|
3.03 units on a scale
Standard Deviation 0.734
|
3.44 units on a scale
Standard Deviation 0.447
|
3.08 units on a scale
Standard Deviation 0.685
|
2.83 units on a scale
Standard Deviation 0.612
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Per Protocol Population (PP)
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 6. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Itching at Day 6
3 minutes post-CAC
|
2.17 units on a scale
Standard Deviation 0.781
|
2.19 units on a scale
Standard Deviation 1.108
|
2.06 units on a scale
Standard Deviation 0.904
|
2.33 units on a scale
Standard Deviation 0.76
|
|
Ocular Itching at Day 6
5 minutes post-CAC
|
2.44 units on a scale
Standard Deviation 0.778
|
2.59 units on a scale
Standard Deviation 0.954
|
2.41 units on a scale
Standard Deviation 0.963
|
2.53 units on a scale
Standard Deviation 0.824
|
|
Ocular Itching at Day 6
7 minutes post-CAC
|
2.17 units on a scale
Standard Deviation 0.968
|
2.72 units on a scale
Standard Deviation 0.891
|
2.31 units on a scale
Standard Deviation 1.007
|
2.14 units on a scale
Standard Deviation 0.674
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Per Protocol Population (PP)
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 7. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Itching at Day 7
3 minutes post-CAC
|
2.11 units on a scale
Standard Deviation 0.858
|
2.28 units on a scale
Standard Deviation 1.004
|
2.09 units on a scale
Standard Deviation 1.069
|
2.03 units on a scale
Standard Deviation 1.064
|
|
Ocular Itching at Day 7
5 minutes post-CAC
|
2.11 units on a scale
Standard Deviation 0.894
|
2.69 units on a scale
Standard Deviation 1.007
|
2.03 units on a scale
Standard Deviation 0.85
|
1.94 units on a scale
Standard Deviation 1.108
|
|
Ocular Itching at Day 7
7 minutes post-CAC
|
1.97 units on a scale
Standard Deviation 0.956
|
2.75 units on a scale
Standard Deviation 0.896
|
1.88 units on a scale
Standard Deviation 0.982
|
1.72 units on a scale
Standard Deviation 0.93
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Per Protocol Population (PP)
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 27. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Itching at Day 27
5 minutes post-CAC
|
2.17 units on a scale
Standard Deviation 1.281
|
2.64 units on a scale
Standard Deviation 1.189
|
2.09 units on a scale
Standard Deviation 1.239
|
1.84 units on a scale
Standard Deviation 0.801
|
|
Ocular Itching at Day 27
3 minutes post-CAC
|
2.14 units on a scale
Standard Deviation 1.119
|
2.43 units on a scale
Standard Deviation 1.231
|
1.75 units on a scale
Standard Deviation 1.433
|
2.03 units on a scale
Standard Deviation 0.871
|
|
Ocular Itching at Day 27
7 minutes post-CAC
|
2.03 units on a scale
Standard Deviation 1.314
|
2.64 units on a scale
Standard Deviation 1.189
|
2 units on a scale
Standard Deviation 1.382
|
1.72 units on a scale
Standard Deviation 0.807
|
PRIMARY outcome
Timeframe: 3, 5, 7 minutes post-CACPopulation: Intent to Treat (ITT)
Post-CAC ocular itching from Day 0 will be compared to post-CAC ocular itching, post-instillation, on Day 28. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=7 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Itching at Day 28
3 minutes post-CAC
|
1.83 units on a scale
Standard Deviation 1.111
|
2.25 units on a scale
Standard Deviation 1.267
|
2.03 units on a scale
Standard Deviation 1.404
|
1.75 units on a scale
Standard Deviation 0.835
|
|
Ocular Itching at Day 28
5 minutes post-CAC
|
1.97 units on a scale
Standard Deviation 1.343
|
2.64 units on a scale
Standard Deviation 1.24
|
2 units on a scale
Standard Deviation 1.482
|
1.78 units on a scale
Standard Deviation 0.901
|
|
Ocular Itching at Day 28
7 minutes post-CAC
|
1.89 units on a scale
Standard Deviation 1.426
|
2.71 units on a scale
Standard Deviation 1.228
|
1.78 units on a scale
Standard Deviation 1.417
|
1.56 units on a scale
Standard Deviation 0.853
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Full Analysis Set
A baseline CAC was performed on Day 0. Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6, Day 7, Day 27 and Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Redness at Baseline (Day 0)
7 minutes post-CAC
|
2.11 units on a scale
Standard Deviation 0.651
|
2.11 units on a scale
Standard Deviation 0.532
|
1.86 units on a scale
Standard Deviation 0.333
|
2.08 units on a scale
Standard Deviation 0.354
|
|
Ocular Redness at Baseline (Day 0)
15 minutes post-CAC
|
2.33 units on a scale
Standard Deviation 0.573
|
2.31 units on a scale
Standard Deviation 0.349
|
2.11 units on a scale
Standard Deviation 0.182
|
2.25 units on a scale
Standard Deviation 0.415
|
|
Ocular Redness at Baseline (Day 0)
20 minutes post-CAC
|
2.22 units on a scale
Standard Deviation 0.537
|
2.28 units on a scale
Standard Deviation 0.384
|
2 units on a scale
Standard Deviation 0.125
|
2.06 units on a scale
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per Protocol Population (PP)
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 6. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Redness at Day 6
7 minutes post-CAC
|
2 units on a scale
Standard Deviation 0.515
|
2.22 units on a scale
Standard Deviation 0.508
|
1.84 units on a scale
Standard Deviation 0.823
|
2.11 units on a scale
Standard Deviation 0.858
|
|
Ocular Redness at Day 6
15 minutes post-CAC
|
1.97 units on a scale
Standard Deviation 0.775
|
2.41 units on a scale
Standard Deviation 0.626
|
2.13 units on a scale
Standard Deviation 0.327
|
2.28 units on a scale
Standard Deviation 0.996
|
|
Ocular Redness at Day 6
20 minutes post-CAC
|
2 units on a scale
Standard Deviation 0.866
|
2.31 units on a scale
Standard Deviation 0.691
|
2.03 units on a scale
Standard Deviation 0.452
|
2.17 units on a scale
Standard Deviation 0.992
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Per Protocol Population (PP)
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 7. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Redness at Day 7
7 minutes post-CAC
|
2.08 units on a scale
Standard Deviation 0.451
|
1.53 units on a scale
Standard Deviation 0.761
|
1.59 units on a scale
Standard Deviation 0.706
|
1.59 units on a scale
Standard Deviation 0.778
|
|
Ocular Redness at Day 7
15 minutes post-CAC
|
1.83 units on a scale
Standard Deviation 0.791
|
1.69 units on a scale
Standard Deviation 0.894
|
1.59 units on a scale
Standard Deviation 0.706
|
1.66 units on a scale
Standard Deviation 0.981
|
|
Ocular Redness at Day 7
20 minutes post-CAC
|
1.72 units on a scale
Standard Deviation 0.765
|
1.78 units on a scale
Standard Deviation 0.986
|
1.47 units on a scale
Standard Deviation 0.737
|
1.5 units on a scale
Standard Deviation 0.973
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 27. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=7 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Redness at Day 27
7 minutes post-CAC
|
1.72 units on a scale
Standard Deviation 0.701
|
2.14 units on a scale
Standard Deviation 0.349
|
1.44 units on a scale
Standard Deviation 0.32
|
1.56 units on a scale
Standard Deviation 0.776
|
|
Ocular Redness at Day 27
15 minutes post-CAC
|
1.72 units on a scale
Standard Deviation 0.723
|
2.11 units on a scale
Standard Deviation 0.476
|
1.63 units on a scale
Standard Deviation 0.567
|
1.72 units on a scale
Standard Deviation 0.674
|
|
Ocular Redness at Day 27
20 minutes post-CAC
|
1.53 units on a scale
Standard Deviation 0.814
|
1.89 units on a scale
Standard Deviation 0.575
|
1.53 units on a scale
Standard Deviation 0.558
|
1.72 units on a scale
Standard Deviation 0.749
|
PRIMARY outcome
Timeframe: 7, 15, 20 minutes post-CACPopulation: Intent to Treat (ITT)
Post-CAC ocular redness from Day 0 will be compared to post-CAC ocular redness, post-instillation, on Day 28. Ocular redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular redness score over both eyes was analyzed.
Outcome measures
| Measure |
Pred Forte
n=9 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Pred Mild
n=7 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Alrex
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
Tears Naturale
n=8 Participants
1 drop in each eye up to 4 times daily for up to 4 weeks
|
|---|---|---|---|---|
|
Ocular Redness at Day 28
7 minutes post-CAC
|
1.58 units on a scale
Standard Deviation 0.82
|
1.96 units on a scale
Standard Deviation 0.393
|
1.69 units on a scale
Standard Deviation 0.637
|
1.81 units on a scale
Standard Deviation 0.788
|
|
Ocular Redness at Day 28
15 minutes post-CAC
|
1.81 units on a scale
Standard Deviation 0.827
|
2.11 units on a scale
Standard Deviation 0.378
|
1.69 units on a scale
Standard Deviation 0.753
|
1.94 units on a scale
Standard Deviation 0.863
|
|
Ocular Redness at Day 28
20 minutes post-CAC
|
1.5 units on a scale
Standard Deviation 0.791
|
1.86 units on a scale
Standard Deviation 0.476
|
1.69 units on a scale
Standard Deviation 0.717
|
1.72 units on a scale
Standard Deviation 0.761
|
Adverse Events
Pred Forte
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pred Mild
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Alrex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tears Naturale
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pred Forte
n=9 participants at risk
1 drop in each eye up to 4 times daily during a 4 week period
|
Pred Mild
n=9 participants at risk
1 drop in each eye up to 4 times daily during a 4 week period
|
Alrex
n=9 participants at risk
1 drop in each eye up to 4 times daily during a 4 week period
|
Tears Naturale
n=9 participants at risk
1 drop in each eye up to 4 times daily during a 4 week period
|
|---|---|---|---|---|
|
Eye disorders
Stinging upon instillation of dose 1 QD (Morning dose every day)
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Eye disorders
Increase in IOP (5 unit)
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
General disorders
Taste Perversion
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Eye disorders
Burning upon instillation
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Eye disorders
Lower lid swelling
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Skin and subcutaneous tissue disorders
Itching secondary to Posion Ivy
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
General disorders
Worsening of Rhinitis 1 hour after instillation of Dose 1
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
General disorders
Worsening of Headache
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
Eye disorders
Ocular fatigue sensation
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
|
General disorders
Taste perversion upon instillation
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
0.00%
0/9 • Adverse events were assessed through study completion, approximately one month. All subjects who received study medication were evaluable for the safety analysis.
Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place