Trial Outcomes & Findings for Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR) (NCT NCT00818805)
NCT ID: NCT00818805
Last Updated: 2012-06-04
Results Overview
Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
0-180 minutes after entering the examination room
Results posted on
2012-06-04
Participant Flow
The recruitment period: May 21-31, 2008 Location: Samoncho Clinic
The study was conducted using an Ohio chamber in two parts: 1) a proof-of concept pilot study designed to assess the appropriateness of the OHIO chamber to induce ocular symptoms. 2) a randomized, single-masked, placebo-controlled, cross-over study.
Participant milestones
| Measure |
Olopatadine 0.1% First, Then Tranilast Second
Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next
|
Tranilast 0.5% First, Then Olopatadine Second
Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
25
|
|
First Intervention
COMPLETED
|
25
|
25
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
25
|
25
|
|
Second Intervention
COMPLETED
|
25
|
25
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Investigation Study of Olopatadine Hydrochloride Ophthalmic Solution Using OHIO Chamber in Patients With Seasonal Allergic Rhinitis (SAR)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=50 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-180 minutes after entering the examination roomOcular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
Outcome measures
| Measure |
Olopatadine 0.1% One Eye
n=50 Participants
Olopatadine 0.1% in one eye in either the first or second period
|
Tranilast 0.5% One Eye
n=50 Participants
Tranilast 0.5% in one eye in either the first or second period
|
Placebo (Olopatadine)
n=50 Participants
Placebo (Olopatadine) in one eye in either the first or second period
|
Placebo (Tranilast)
n=50 Participants
Placebo (Tranilast) in one eye in either the first or second period
|
|---|---|---|---|---|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
15 minutes
|
0.19 Units on a scale
Standard Deviation 0.47
|
0.11 Units on a scale
Standard Deviation 0.46
|
0.06 Units on a scale
Standard Deviation 0.33
|
0.08 Units on a scale
Standard Deviation 0.44
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
30 minutes
|
0.44 Units on a scale
Standard Deviation 0.61
|
0.25 Units on a scale
Standard Deviation 0.50
|
0.33 Units on a scale
Standard Deviation 0.53
|
0.28 Units on a scale
Standard Deviation 0.51
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
45 minutes
|
0.50 Units on a scale
Standard Deviation 0.70
|
0.36 Units on a scale
Standard Deviation 0.68
|
0.50 Units on a scale
Standard Deviation 0.65
|
0.56 Units on a scale
Standard Deviation 0.69
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
60 minutes
|
0.67 Units on a scale
Standard Deviation 0.76
|
0.50 Units on a scale
Standard Deviation 0.74
|
0.75 Units on a scale
Standard Deviation 0.69
|
0.61 Units on a scale
Standard Deviation 0.73
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
75 minutes
|
0.81 Units on a scale
Standard Deviation 0.82
|
0.67 Units on a scale
Standard Deviation 0.79
|
0.92 Units on a scale
Standard Deviation 0.81
|
0.78 Units on a scale
Standard Deviation 0.76
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
90 minutes
|
0.92 Units on a scale
Standard Deviation 0.81
|
0.86 Units on a scale
Standard Deviation 0.72
|
0.92 Units on a scale
Standard Deviation 0.69
|
0.94 Units on a scale
Standard Deviation 0.75
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
105 minutes
|
0.94 Units on a scale
Standard Deviation 0.58
|
0.86 Units on a scale
Standard Deviation 0.72
|
1.03 Units on a scale
Standard Deviation 0.70
|
0.97 Units on a scale
Standard Deviation 0.81
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
120 minutes
|
1.03 Units on a scale
Standard Deviation 0.65
|
1.03 Units on a scale
Standard Deviation 0.70
|
1.19 Units on a scale
Standard Deviation 0.67
|
1.08 Units on a scale
Standard Deviation 0.81
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
135 minutes
|
1.17 Units on a scale
Standard Deviation 0.70
|
1.14 Units on a scale
Standard Deviation 0.72
|
1.33 Units on a scale
Standard Deviation 0.72
|
1.19 Units on a scale
Standard Deviation 0.82
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
150 minutes
|
1.25 Units on a scale
Standard Deviation 0.77
|
1.14 Units on a scale
Standard Deviation 0.76
|
1.36 Units on a scale
Standard Deviation 0.64
|
1.25 Units on a scale
Standard Deviation 0.77
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
165 minutes
|
1.28 Units on a scale
Standard Deviation 0.78
|
1.14 Units on a scale
Standard Deviation 0.76
|
1.39 Units on a scale
Standard Deviation 0.64
|
1.33 Units on a scale
Standard Deviation 0.76
|
|
Change in "Ocular Itching" Score (5-point Scale) in Subjective Symptom Questionnaire
180 minutes
|
1.39 Units on a scale
Standard Deviation 0.77
|
1.39 Units on a scale
Standard Deviation 0.77
|
1.44 Units on a scale
Standard Deviation 0.69
|
1.47 Units on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: 15-180 min.Outcome measures
Outcome data not reported
Adverse Events
Olopatadine 0.1% One Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tranilast 0.5% One Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Olopatadine) One Eye
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Tranilast) One Eye
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