Trial Outcomes & Findings for Olopatadine Eye Drops and Allergy Skin Testing (NCT NCT00775658)
NCT ID: NCT00775658
Last Updated: 2017-07-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
at baseline and at return visit (between study day 7-10)
Results posted on
2017-07-12
Participant Flow
Three participants withdrew prior to any study procedure: 1 had and upper respiratory infection, 1 required use of oral anti histamine and 1 was lost to follow up
Participant milestones
| Measure |
Olopatadine Then Placebo
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
|
Placebo Then Olopatadine
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
11
|
|
First Intervention
COMPLETED
|
10
|
11
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
11
|
|
Second Intervention
COMPLETED
|
10
|
11
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olopatadine Eye Drops and Allergy Skin Testing
Baseline characteristics by cohort
| Measure |
All Participants
n=21 Participants
Includes both groups of participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at baseline and at return visit (between study day 7-10)Outcome measures
| Measure |
Olopatadine
n=21 Participants
double blind crossover
|
Placebo
n=21 Participants
|
|---|---|---|
|
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
|
0.461 cm2
Standard Deviation 0.279
|
0.464 cm2
Standard Deviation 0.254
|
PRIMARY outcome
Timeframe: at baseline and at return visit (between study day 7-10)Population: Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.
Outcome measures
| Measure |
Olopatadine
n=21 Participants
double blind crossover
|
Placebo
n=21 Participants
|
|---|---|---|
|
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
|
6.95 cm2
Standard Deviation 4.68
|
8.31 cm2
Standard Deviation 3.98
|
Adverse Events
Olopatadine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place