Trial Outcomes & Findings for Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model (NCT NCT01730872)
NCT ID: NCT01730872
Last Updated: 2019-06-19
Results Overview
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
90 minutes post CAC
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Prednisolone
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
|
Placebo
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
Control
Subjects received CAC using saline instead of allergen
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
5
|
3
|
|
Overall Study
Full Analysis Set
|
8
|
4
|
0
|
|
Overall Study
COMPLETED
|
8
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
Baseline characteristics by cohort
| Measure |
Prednisolone
n=8 Participants
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
|
Placebo
n=5 Participants
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
Saline
n=3 Participants
A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.75 years
STANDARD_DEVIATION 1.461897 • n=5 Participants
|
37.2 years
STANDARD_DEVIATION 1.830301 • n=7 Participants
|
39.33 years
STANDARD_DEVIATION 0.905539 • n=5 Participants
|
39.88 years
STANDARD_DEVIATION 0.0707107 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 minutes post CACPopulation: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Outcome measures
| Measure |
Prednisolone
n=8 Participants
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
|
Placebo
n=4 Participants
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
|---|---|---|
|
Inflammation Change From Baseline to Day 6
|
-1.2 score on a scale
Standard Deviation 0.78
|
-0.19 score on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 7 minutes post-CACPopulation: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
Outcome measures
| Measure |
Prednisolone
n=8 Participants
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
|
Placebo
n=4 Participants
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
|---|---|---|
|
Ocular Itching Change From Baseline to Day 6
|
-1.1 score on a scale
Standard Deviation 1.30
|
-1.0 score on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 7 minutes post-CACPopulation: The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
Outcome measures
| Measure |
Prednisolone
n=8 Participants
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
|
Placebo
n=4 Participants
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
|---|---|---|
|
Ocular Redness Change From Baseline to Day 6
|
-1.1 score on a scale
Standard Deviation 1.38
|
0.31 score on a scale
Standard Deviation 1.01
|
Adverse Events
Prednisolone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Saline
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 |
Prednisolone
n=8 participants at risk
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days.
|
Placebo
n=5 participants at risk
Tears Naturale II Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
|
Saline
n=3 participants at risk
A group of five allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.
|
|---|---|---|---|
|
Eye disorders
peri-ocular lid redness
|
12.5%
1/8 • Number of events 1 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
0.00%
0/5 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
0.00%
0/3 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
|
Musculoskeletal and connective tissue disorders
lower leg pain
|
12.5%
1/8 • Number of events 1 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
0.00%
0/5 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
0.00%
0/3 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
|
Eye disorders
endothelial pigment
|
0.00%
0/8 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
20.0%
1/5 • Number of events 1 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
0.00%
0/3 • AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place