Trial Outcomes & Findings for A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis (NCT NCT01470118)
NCT ID: NCT01470118
Last Updated: 2013-02-21
Results Overview
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
COMPLETED
PHASE4
127 participants
Day 0 Hour 16
2013-02-21
Participant Flow
Participant milestones
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
41
|
|
Overall Study
COMPLETED
|
38
|
38
|
39
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis
Baseline characteristics by cohort
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
39.3 Years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 14.84 • n=7 Participants
|
39.3 Years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
38.5 Years
STANDARD_DEVIATION 13.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 Hour 16Population: Intent-to-Treat: All randomized subjects
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
3 Minutes
|
0.62 Scores on a Scale
Standard Deviation 0.716
|
1.01 Scores on a Scale
Standard Deviation 0.8211
|
2.14 Scores on a Scale
Standard Deviation 0.864
|
|
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
5 Minutes
|
0.93 Scores on a Scale
Standard Deviation 0.789
|
1.13 Scores on a Scale
Standard Deviation 0.852
|
2.35 Scores on a Scale
Standard Deviation 0.759
|
|
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
7 Minutes
|
1.07 Scores on a Scale
Standard Deviation 0.830
|
1.12 Scores on a Scale
Standard Deviation 0.824
|
2.20 Scores on a Scale
Standard Deviation 0.888
|
PRIMARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
3 Minutes
|
0.64 Scores on a Scale
Standard Deviation 0.807
|
0.97 Scores on a Scale
Standard Deviation 0.771
|
2.27 Scores on a Scale
Standard Deviation 0.846
|
|
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
5 Minutes
|
0.84 Scores on a Scale
Standard Deviation 0.851
|
1.16 Scores on a Scale
Standard Deviation 0.886
|
2.19 Scores on a Scale
Standard Deviation 0.897
|
|
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
0.93 Scores on a Scale
Standard Deviation 0.911
|
1.01 Scores on a Scale
Standard Deviation 0.932
|
1.96 Scores on a Scale
Standard Deviation 1.068
|
SECONDARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
1.74 Scores on a Scale
Standard Deviation 0.612
|
1.78 Scores on a Scale
Standard Deviation 0.709
|
2.08 Scores on a Scale
Standard Deviation 0.605
|
|
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
15 Minutes
|
2.01 Scores on a Scale
Standard Deviation 0.672
|
2.01 Scores on a Scale
Standard Deviation 0.805
|
2.22 Scores on a Scale
Standard Deviation 0.671
|
|
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
20 Minutes
|
1.99 Scores on a Scale
Standard Deviation 0.652
|
1.92 Scores on a Scale
Standard Deviation 0.870
|
2.20 Scores on a Scale
Standard Deviation 0.691
|
SECONDARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
1.36 Scores on a Scale
Standard Deviation 0.730
|
1.47 Scores on a Scale
Standard Deviation 0.773
|
1.83 Scores on a Scale
Standard Deviation 0.764
|
|
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
15 Minutes
|
1.64 Scores on a Scale
Standard Deviation 0.805
|
1.67 Scores on a Scale
Standard Deviation 0.901
|
2.00 Scores on a Scale
Standard Deviation 0.772
|
|
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
20 Minutes
|
1.67 Scores on a Scale
Standard Deviation 0.754
|
1.65 Scores on a Scale
Standard Deviation 0.909
|
1.94 Scores on a Scale
Standard Deviation 0.844
|
SECONDARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
1.65 Scores on a Scale
Standard Deviation 0.667
|
1.56 Scores on a Scale
Standard Deviation 0.827
|
2.01 Scores on a Scale
Standard Deviation 0.682
|
|
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
15 Minutes
|
1.95 Scores on a Scale
Standard Deviation 0.649
|
1.82 Scores on a Scale
Standard Deviation 0.924
|
2.15 Scores on a Scale
Standard Deviation 0.727
|
|
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
20 Minutes
|
1.91 Scores on a Scale
Standard Deviation 0.645
|
1.79 Scores on a Scale
Standard Deviation 0.960
|
2.13 Scores on a Scale
Standard Deviation 0.718
|
SECONDARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
0.90 Scores on a Scale
Standard Deviation 0.392
|
0.97 Scores on a Scale
Standard Deviation 0.479
|
1.15 Scores on a Scale
Standard Deviation 0.505
|
|
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
15 Minutes
|
1.03 Scores on a Scale
Standard Deviation 0.403
|
1.09 Scores on a Scale
Standard Deviation 0.616
|
1.34 Scores on a Scale
Standard Deviation 0.668
|
|
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
20 Minutes
|
1.14 Scores on a Scale
Standard Deviation 0.457
|
1.13 Scores on a Scale
Standard Deviation 0.677
|
1.42 Scores on a Scale
Standard Deviation 0.742
|
SECONDARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
0.4 Scores on a Scale
Standard Deviation 0.62
|
0.4 Scores on a Scale
Standard Deviation 0.51
|
1.0 Scores on a Scale
Standard Deviation 0.75
|
|
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
15 Minutes
|
0.5 Scores on a Scale
Standard Deviation 0.66
|
0.6 Scores on a Scale
Standard Deviation 0.74
|
1.0 Scores on a Scale
Standard Deviation 0.88
|
|
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
20 Minutes
|
0.6 Scores on a Scale
Standard Deviation 0.65
|
0.6 Scores on a Scale
Standard Deviation 0.77
|
1.1 Scores on a Scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Day 14 Hour 24Population: Intent-to-Treat: All randomized subjects
Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.
Outcome measures
| Measure |
LASTACAFT® (Alcaftadine 0.25%)
n=43 Participants
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Pataday™ (Olopatadine 0.2%)
n=43 Participants
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
|
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
n=41 Participants
One drop of placebo instilled in each eye at Day 0 and Day 14.
|
|---|---|---|---|
|
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
7 Minutes
|
0.3 Scores on a Scale
Standard Deviation 0.49
|
0.4 Scores on a Scale
Standard Deviation 0.81
|
1.0 Scores on a Scale
Standard Deviation 0.91
|
|
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
15 Minutes
|
0.5 Scores on a Scale
Standard Deviation 0.62
|
0.6 Scores on a Scale
Standard Deviation 0.93
|
0.9 Scores on a Scale
Standard Deviation 0.87
|
|
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
20 Minutes
|
0.5 Scores on a Scale
Standard Deviation 0.60
|
0.6 Scores on a Scale
Standard Deviation 1.03
|
0.8 Scores on a Scale
Standard Deviation 0.86
|
Adverse Events
LASTACAFT® (Alcaftadine 0.25%)
Pataday™ (Olopatadine 0.2%)
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
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 A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
- Publication restrictions are in place
Restriction type: OTHER