Trial Outcomes & Findings for Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan (NCT NCT02251613)
NCT ID: NCT02251613
Last Updated: 2015-10-07
Results Overview
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).
COMPLETED
PHASE4
50 participants
Day 1, 7 minutes post-CAC
2015-10-07
Participant Flow
Participants were recruited from 1 study site located in Japan.
All subjects qualifying for treatment at Visit 3 were randomized. This reporting group includes all randomized participants (50).
Participant milestones
| Measure |
Overall
Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
Baseline characteristics by cohort
| Measure |
Overall
n=50 Participants
Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
|
|---|---|
|
Age, Customized
20-29 years
|
22 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
13 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
14 participants
n=5 Participants
|
|
Age, Customized
≥50 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, 7 minutes post-CACPopulation: This analysis population includes all randomized participants.
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).
Outcome measures
| Measure |
Olopatadine 0.1%
n=50 eyes
Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
|
Epinastine 0.05%
n=50 eyes
Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
|
|---|---|---|
|
Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
|
0.23 units on a scale
Standard Deviation 0.31
|
0.37 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Day 1, 20 minutes post-CACPopulation: This analysis population includes all randomized participants.
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).
Outcome measures
| Measure |
Olopatadine 0.1%
n=50 eyes
Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
|
Epinastine 0.05%
n=50 eyes
Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
|
|---|---|---|
|
Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
|
0.89 units on a scale
Standard Deviation 0.88
|
1.12 units on a scale
Standard Deviation 0.95
|
Adverse Events
Olopatadine 0.1%
Epinastine 0.05%
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Hironari Sakaguchi, Phase IV Clinical & Regulatory Affairs, Japan
Alcon Japan, Ltd.
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