Conjunctivitis, Allergic
Conditions
Brief summary
This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.
Interventions
DRUGalcaftadine 0.25% ophthalmic solution
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
DRUGolopatadine 0.2% ophthalmic solution
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
One drop of placebo instilled in each eye at Day 0 and Day 14.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of eye allergies within the past 24 months * Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period
Exclusion criteria
* Current eye infection * Eye surgery within 3 months or vision correction surgery within 6 months * Any planned surgery during the study or 30 days after the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | Day 0 Hour 16 | 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. |
| Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
| Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
| Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
| Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
| Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
| Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | Day 14 Hour 24 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LASTACAFT® (Alcaftadine 0.25%) One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. | 43 |
| Pataday™ (Olopatadine 0.2%) One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. | 43 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) One drop of placebo instilled in each eye at Day 0 and Day 14. | 41 |
| Total | 127 |
Baseline characteristics
| Characteristic | LASTACAFT® (Alcaftadine 0.25%) | Pataday™ (Olopatadine 0.2%) | Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Total |
|---|---|---|---|---|
| Age Continuous | 39.3 Years STANDARD_DEVIATION 12.44 | 37.0 Years STANDARD_DEVIATION 14.84 | 39.3 Years STANDARD_DEVIATION 12.31 | 38.5 Years STANDARD_DEVIATION 13.21 |
| Sex: Female, Male Female | 31 Participants | 33 Participants | 28 Participants | 92 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 13 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 42 | 0 / 41 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 | 0 / 41 |
Outcome results
Primary
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
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.
Time frame: Day 0 Hour 16
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 0.83 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | 5 Minutes | 1.13 Scores on a Scale | Standard Deviation 0.852 |
| Pataday™ (Olopatadine 0.2%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | 3 Minutes | 1.01 Scores on a Scale | Standard Deviation 0.8211 |
| Pataday™ (Olopatadine 0.2%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | 7 Minutes | 1.12 Scores on a Scale | Standard Deviation 0.824 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | 7 Minutes | 2.20 Scores on a Scale | Standard Deviation 0.888 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | 5 Minutes | 2.35 Scores on a Scale | Standard Deviation 0.759 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 | 3 Minutes | 2.14 Scores on a Scale | Standard Deviation 0.864 |
Primary
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.01 Scores on a Scale | Standard Deviation 0.932 |
| Pataday™ (Olopatadine 0.2%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | 3 Minutes | 0.97 Scores on a Scale | Standard Deviation 0.771 |
| Pataday™ (Olopatadine 0.2%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | 5 Minutes | 1.16 Scores on a Scale | Standard Deviation 0.886 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | 3 Minutes | 2.27 Scores on a Scale | Standard Deviation 0.846 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | 5 Minutes | 2.19 Scores on a Scale | Standard Deviation 0.897 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.96 Scores on a Scale | Standard Deviation 1.068 |
Secondary
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.13 Scores on a Scale | Standard Deviation 0.677 |
| Pataday™ (Olopatadine 0.2%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 0.97 Scores on a Scale | Standard Deviation 0.479 |
| Pataday™ (Olopatadine 0.2%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 1.09 Scores on a Scale | Standard Deviation 0.616 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.42 Scores on a Scale | Standard Deviation 0.742 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.15 Scores on a Scale | Standard Deviation 0.505 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 1.34 Scores on a Scale | Standard Deviation 0.668 |
Secondary
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 0.73 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 1.67 Scores on a Scale | Standard Deviation 0.901 |
| Pataday™ (Olopatadine 0.2%) | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.47 Scores on a Scale | Standard Deviation 0.773 |
| Pataday™ (Olopatadine 0.2%) | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.65 Scores on a Scale | Standard Deviation 0.909 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.83 Scores on a Scale | Standard Deviation 0.764 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.94 Scores on a Scale | Standard Deviation 0.844 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 2.00 Scores on a Scale | Standard Deviation 0.772 |
Secondary
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.92 Scores on a Scale | Standard Deviation 0.87 |
| Pataday™ (Olopatadine 0.2%) | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.78 Scores on a Scale | Standard Deviation 0.709 |
| Pataday™ (Olopatadine 0.2%) | 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 0.805 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 2.20 Scores on a Scale | Standard Deviation 0.691 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 2.22 Scores on a Scale | Standard Deviation 0.671 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 2.08 Scores on a Scale | Standard Deviation 0.605 |
Secondary
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.56 Scores on a Scale | Standard Deviation 0.827 |
| Pataday™ (Olopatadine 0.2%) | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.79 Scores on a Scale | Standard Deviation 0.96 |
| Pataday™ (Olopatadine 0.2%) | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 1.82 Scores on a Scale | Standard Deviation 0.924 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 2.01 Scores on a Scale | Standard Deviation 0.682 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 2.13 Scores on a Scale | Standard Deviation 0.718 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 2.15 Scores on a Scale | Standard Deviation 0.727 |
Secondary
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| Pataday™ (Olopatadine 0.2%) | 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 0.51 |
| Pataday™ (Olopatadine 0.2%) | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 0.6 Scores on a Scale | Standard Deviation 0.74 |
| Pataday™ (Olopatadine 0.2%) | 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 0.77 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 1.1 Scores on a Scale | Standard Deviation 0.87 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 1.0 Scores on a Scale | Standard Deviation 0.88 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.0 Scores on a Scale | Standard Deviation 0.75 |
Secondary
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
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.
Time frame: Day 14 Hour 24
Population: Intent-to-Treat: All randomized subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 |
| LASTACAFT® (Alcaftadine 0.25%) | 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 0.6 |
| Pataday™ (Olopatadine 0.2%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 0.6 Scores on a Scale | Standard Deviation 0.93 |
| Pataday™ (Olopatadine 0.2%) | Tearing 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 0.81 |
| Pataday™ (Olopatadine 0.2%) | Tearing 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 1.03 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 7 Minutes | 1.0 Scores on a Scale | Standard Deviation 0.91 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 20 Minutes | 0.8 Scores on a Scale | Standard Deviation 0.86 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 | 15 Minutes | 0.9 Scores on a Scale | Standard Deviation 0.87 |