Conjunctivitis, Allergic
Conditions
Brief summary
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.
Interventions
DRUGAlcaftadine 0.25%
One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
DRUGOlopatadine 0.2%
One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
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 ocular allergies within the past 24 months. * Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.
Exclusion criteria
* Any presence of active ocular infection or history of an ocular herpetic infection. * Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months. * Have 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 3 Minutes Post Challenge on Day 0 | Day 0 at 3 Minutes Post Challenge | Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | Day 0 | Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score \<1. |
| Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | Day 0 | Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0. |
| Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | Day 0 | Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). |
| Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | Day 0 | The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness. |
| Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | Day 0 | Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching. |
| Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | Day 0 | The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness. |
| Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | Day 0 | Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis. |
| Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | Day 0 | Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling. |
| Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | Day 0 | Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score 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 is averaged (i.e., one score per subject). A lower score is indicative of less tearing. |
| Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | Day 0 | Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lastacaft® One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0. | 53 |
| Pataday™ One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0. | 52 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0. | 52 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Lastacaft® | Pataday™ | Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Total |
|---|---|---|---|---|
| Age, Continuous | 38.2 Years STANDARD_DEVIATION 13.78 | 38.7 Years STANDARD_DEVIATION 15.1 | 34.7 Years STANDARD_DEVIATION 12.58 | 37.2 Years STANDARD_DEVIATION 13.88 |
| Sex: Female, Male Female | 32 Participants | 29 Participants | 26 Participants | 87 Participants |
| Sex: Female, Male Male | 21 Participants | 23 Participants | 26 Participants | 70 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 / 53 | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 | 0 / 52 |
Outcome results
Primary
Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
Time frame: Day 0 at 3 Minutes Post Challenge
Population: All randomized subjects with data at this time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lastacaft® | Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0 | 0.40 Scores on a Scale | Standard Deviation 0.582 |
| Pataday™ | Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0 | 0.76 Scores on a Scale | Standard Deviation 0.752 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0 | 2.00 Scores on a Scale | Standard Deviation 1.109 |
Secondary
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.62 Scores on a Scale | Standard Deviation 0.576 |
| Lastacaft® | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.37 Scores on a Scale | Standard Deviation 0.433 |
| Lastacaft® | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.73 Scores on a Scale | Standard Deviation 0.679 |
| Pataday™ | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.51 Scores on a Scale | Standard Deviation 0.562 |
| Pataday™ | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.27 Scores on a Scale | Standard Deviation 0.35 |
| Pataday™ | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.56 Scores on a Scale | Standard Deviation 0.634 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.51 Scores on a Scale | Standard Deviation 0.511 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.96 Scores on a Scale | Standard Deviation 0.757 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.76 Scores on a Scale | Standard Deviation 0.691 |
Secondary
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 1.97 Scores on a Scale | Standard Deviation 0.845 |
| Lastacaft® | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 1.62 Scores on a Scale | Standard Deviation 0.889 |
| Lastacaft® | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 2.06 Scores on a Scale | Standard Deviation 0.831 |
| Pataday™ | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 1.71 Scores on a Scale | Standard Deviation 0.912 |
| Pataday™ | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 1.47 Scores on a Scale | Standard Deviation 0.887 |
| Pataday™ | Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 1.78 Scores on a Scale | Standard Deviation 0.913 |
| 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 0 | 7 Minutes | 2.10 Scores on a Scale | Standard Deviation 0.805 |
| 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 0 | 20 Minutes | 2.13 Scores on a Scale | Standard Deviation 0.903 |
| 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 0 | 15 Minutes | 2.12 Scores on a Scale | Standard Deviation 0.832 |
Secondary
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 2.02 Scores on a Scale | Standard Deviation 0.844 |
| Lastacaft® | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 1.73 Scores on a Scale | Standard Deviation 0.887 |
| Lastacaft® | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 2.10 Scores on a Scale | Standard Deviation 0.854 |
| Pataday™ | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 1.81 Scores on a Scale | Standard Deviation 0.877 |
| Pataday™ | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 1.61 Scores on a Scale | Standard Deviation 0.867 |
| Pataday™ | Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 1.89 Scores on a Scale | Standard Deviation 0.886 |
| 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 0 | 7 Minutes | 2.17 Scores on a Scale | Standard Deviation 0.731 |
| 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 0 | 20 Minutes | 2.22 Scores on a Scale | Standard Deviation 0.83 |
| 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 0 | 15 Minutes | 2.17 Scores on a Scale | Standard Deviation 0.784 |
Secondary
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 1.61 Scores on a Scale | Standard Deviation 0.842 |
| Lastacaft® | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 1.88 Scores on a Scale | Standard Deviation 0.82 |
| Lastacaft® | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 1.97 Scores on a Scale | Standard Deviation 0.837 |
| Pataday™ | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 1.53 Scores on a Scale | Standard Deviation 0.815 |
| Pataday™ | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 1.70 Scores on a Scale | Standard Deviation 0.839 |
| Pataday™ | Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 1.78 Scores on a Scale | Standard Deviation 0.874 |
| 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 0 | 7 Minutes | 2.04 Scores on a Scale | Standard Deviation 0.755 |
| 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 0 | 15 Minutes | 2.04 Scores on a Scale | Standard Deviation 0.828 |
| 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 0 | 20 Minutes | 2.09 Scores on a Scale | Standard Deviation 0.837 |
Secondary
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.4 Scores on a Scale | Standard Deviation 0.51 |
| Lastacaft® | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.4 Scores on a Scale | Standard Deviation 0.51 |
| Lastacaft® | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.2 Scores on a Scale | Standard Deviation 0.48 |
| Pataday™ | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.5 Scores on a Scale | Standard Deviation 0.7 |
| Pataday™ | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.3 Scores on a Scale | Standard Deviation 0.54 |
| Pataday™ | Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.6 Scores on a Scale | Standard Deviation 0.85 |
| 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 0 | 7 Minutes | 0.8 Scores on a Scale | Standard Deviation 0.7 |
| 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 0 | 20 Minutes | 0.7 Scores on a Scale | Standard Deviation 0.76 |
| 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 0 | 15 Minutes | 0.9 Scores on a Scale | Standard Deviation 0.78 |
Secondary
Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 0.61 Scores on a Scale | Standard Deviation 0.663 |
| Lastacaft® | Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 0.69 Scores on a Scale | Standard Deviation 0.724 |
| Pataday™ | Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 0.79 Scores on a Scale | Standard Deviation 0.725 |
| Pataday™ | Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 0.71 Scores on a Scale | Standard Deviation 0.774 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 2.08 Scores on a Scale | Standard Deviation 1.061 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 1.89 Scores on a Scale | Standard Deviation 1.114 |
Secondary
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 1.5 | 3.5 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 4.0 | 0.0 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 2.5 | 4.2 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 2.0 | 5.8 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 0 | 41.7 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 3.5 | 0.0 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 1.0 | 12.5 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 0.5 | 32.1 Percentage of Subject Eyes |
| Lastacaft® | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 3.0 | 0.3 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 2.0 | 6.7 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 0 | 34.3 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 0.5 | 24.0 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 1.0 | 20.8 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 1.5 | 7.7 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 2.5 | 5.1 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 3.0 | 1.3 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 3.5 | 0.0 Percentage of Subject Eyes |
| Pataday™ | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 4.0 | 0.0 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 1.0 | 8.0 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 0 | 8.7 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 3.0 | 15.1 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 0.5 | 10.9 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 4.0 | 4.5 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 2.0 | 17.9 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 1.5 | 6.4 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 3.5 | 5.8 Percentage of Subject Eyes |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0 | 2.5 | 22.8 Percentage of Subject Eyes |
Secondary
Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lastacaft® | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 26.9 Percentage of Subjects |
| Lastacaft® | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 3 Minutes | 48.1 Percentage of Subjects |
| Lastacaft® | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 26.9 Percentage of Subjects |
| Pataday™ | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 26.9 Percentage of Subjects |
| Pataday™ | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 3 Minutes | 26.9 Percentage of Subjects |
| Pataday™ | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 32.7 Percentage of Subjects |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 3 Minutes | 5.8 Percentage of Subjects |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 7.7 Percentage of Subjects |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 3.8 Percentage of Subjects |
Secondary
Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score \<1.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lastacaft® | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 75.0 Percentage of Subjects |
| Lastacaft® | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 3 Minutes | 84.6 Percentage of Subjects |
| Lastacaft® | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 69.2 Percentage of Subjects |
| Pataday™ | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 53.8 Percentage of Subjects |
| Pataday™ | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 3 Minutes | 65.4 Percentage of Subjects |
| Pataday™ | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 61.5 Percentage of Subjects |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 3 Minutes | 21.2 Percentage of Subjects |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 7 Minutes | 25.0 Percentage of Subjects |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0 | 5 Minutes | 21.2 Percentage of Subjects |
Secondary
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score 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 is averaged (i.e., one score per subject). A lower score is indicative of less tearing.
Time frame: Day 0
Population: All randomized subjects with data at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lastacaft® | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.3 Scores on a Scale | Standard Deviation 0.57 |
| Lastacaft® | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.4 Scores on a Scale | Standard Deviation 0.58 |
| Lastacaft® | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.2 Scores on a Scale | Standard Deviation 0.4 |
| Pataday™ | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.6 Scores on a Scale | Standard Deviation 0.83 |
| Pataday™ | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.4 Scores on a Scale | Standard Deviation 0.59 |
| Pataday™ | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.5 Scores on a Scale | Standard Deviation 0.77 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 15 Minutes | 0.8 Scores on a Scale | Standard Deviation 0.93 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 7 Minutes | 0.9 Scores on a Scale | Standard Deviation 0.84 |
| Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) | Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0 | 20 Minutes | 0.7 Scores on a Scale | Standard Deviation 0.94 |