Trial Outcomes & Findings for Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients (NCT NCT01697969)
NCT ID: NCT01697969
Last Updated: 2014-08-18
Results Overview
The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
COMPLETED
PHASE4
17 participants
Baseline (Day 1), Day 14
2014-08-18
Participant Flow
Participants were recruited from 1 study center located in the United States.
Of the 17 participants enrolled, 4 were exited from the study as screen failures prior to exposure to the test product. This reporting group includes all participants exposed to the test product (13).
Participant milestones
| Measure |
Overall Study
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Study
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
|
|---|---|
|
Overall Study
Did not meet inc/exc criteria
|
3
|
Baseline Characteristics
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
Baseline characteristics by cohort
| Measure |
Overall Study
n=13 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
|
|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 14Population: The analysis population includes all participants exposed to the test product. Here, "n" is the number of participants with non-missing values at the specific time point.
The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
Outcome measures
| Measure |
Left Eye
n=13 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
|
Right Eye
n=13 Participants
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
|
|---|---|---|
|
Patient-Assessed Ocular Itching
Baseline (Day 1)
|
2.2 units on a scale
Standard Deviation 0.85
|
2.2 units on a scale
Standard Deviation 0.92
|
|
Patient-Assessed Ocular Itching
Day 14 (n=11)
|
0.5 units on a scale
Standard Deviation 0.52
|
0.5 units on a scale
Standard Deviation 0.52
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study
n=13 participants at risk
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
|
|---|---|
|
Infections and infestations
Arthropod infestation
|
7.7%
1/13 • Adverse events were collected for the duration of the study (October 11, 2012 to July 25, 2013). This analysis group includes all participants exposed to the test product.
At each visit, after the subject had the opportunity to spontaneously mention any problems, the investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit? Have there been any changes in the medicines you take since your last study visit?"
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER