A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01732757
• Collaborator: (none)
• Enrollment: 157
• Location: 1
• Arms: 3
• Duration (Days): 30
• Patients Per Site Per Month: 159.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Allergic	Drug: Alcaftadine 0.25%; Drug: Olopatadine 0.2%; Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lastacaft® One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	Drug: Alcaftadine 0.25%; One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.; Other Names: Lastacaft®
Active Comparator: Pataday™ One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.	Drug: Olopatadine 0.2%; One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.; Other Names: Pataday™
Placebo Comparator: 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.	Drug: 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.; Other Names: Tears Naturale II

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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).

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Memphis	Tennessee	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01732757
• Other Study ID Numbers: GMA-LAS-12-023
• First Posted: Nov 26, 2012
• Last Update Posted: Jan 14, 2014
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Olopatadine Hydrochloride; Dextrans; Alcaftadine

Study Results

Participant Flow

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Period Title: Overall Study
STARTED	53	52	52
COMPLETED	52	52	52
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)	Total
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.	Total of all reporting groups
Overall Participants	53	52	52	157
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.2 (13.78)	38.7 (15.10)	34.7 (12.58)	37.2 (13.88)
Sex: Female, Male (Count of Participants)
Female	32 60.4%	29 55.8%	26 50%	87 55.4%
Male	21 39.6%	23 44.2%	26 50%	70 44.6%

Outcome Measures

1. Primary Outcome

Title	Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
Mean (Standard Deviation) [Scores on a Scale]	0.40 (0.582)	0.76 (0.752)	2.00 (1.109)

2. Secondary Outcome

Title	Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
5 Minutes	0.61 (0.663)	0.79 (0.725)	2.08 (1.061)
7 Minutes	0.69 (0.724)	0.71 (0.774)	1.89 (1.114)

3. Secondary Outcome

Title	Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
3 Minutes	84.6	65.4	21.2
5 Minutes	75.0	53.8	21.2
7 Minutes	69.2	61.5	25.0

4. Secondary Outcome

Title	Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
3 Minutes	48.1	26.9	5.8
5 Minutes	26.9	26.9	3.8
7 Minutes	26.9	32.7	7.7

5. Secondary Outcome

Title	Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
Measure Eyes	104	104	104
0	41.7	34.3	8.7
0.5	32.1	24.0	10.9
1.0	12.5	20.8	8.0
1.5	3.5	7.7	6.4
2.0	5.8	6.7	17.9
2.5	4.2	5.1	22.8
3.0	0.3	1.3	15.1
3.5	0.0	0.0	5.8
4.0	0.0	0.0	4.5

6. Secondary Outcome

Title	Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
7 Minutes	1.73 (0.887)	1.61 (0.867)	2.17 (0.731)
15 Minutes	2.02 (0.844)	1.81 (0.877)	2.17 (0.784)
20 Minutes	2.10 (0.854)	1.89 (0.886)	2.22 (0.830)

7. Secondary Outcome

Title	Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
7 Minutes	1.62 (0.889)	1.47 (0.887)	2.10 (0.805)
15 Minutes	1.97 (0.845)	1.71 (0.912)	2.12 (0.832)
20 Minutes	2.06 (0.831)	1.78 (0.913)	2.13 (0.903)

8. Secondary Outcome

Title	Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
7 Minutes	1.61 (0.842)	1.53 (0.815)	2.04 (0.755)
15 Minutes	1.88 (0.820)	1.70 (0.839)	2.04 (0.828)
20 Minutes	1.97 (0.837)	1.78 (0.874)	2.09 (0.837)

9. Secondary Outcome

Title	Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
7 Minutes	0.37 (0.433)	0.27 (0.350)	0.51 (0.511)
15 Minutes	0.62 (0.576)	0.51 (0.562)	0.76 (0.691)
20 Minutes	0.73 (0.679)	0.56 (0.634)	0.96 (0.757)

10. Secondary Outcome

Title	Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
7 Minutes	0.2 (0.48)	0.3 (0.54)	0.8 (0.70)
15 Minutes	0.4 (0.51)	0.5 (0.70)	0.9 (0.78)
20 Minutes	0.4 (0.51)	0.6 (0.85)	0.7 (0.76)

11. Secondary Outcome

Title	Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Description	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

Outcome Measure Data

Analysis Population Description

All randomized subjects with data at this time point

Arm/Group Title	Lastacaft®	Pataday™	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.	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.
Measure Participants	52	52	52
7 Minutes	0.2 (0.40)	0.4 (0.59)	0.9 (0.84)
15 Minutes	0.4 (0.58)	0.5 (0.77)	0.8 (0.93)
20 Minutes	0.3 (0.57)	0.6 (0.83)	0.7 (0.94)

Adverse Events

Arm/Group Title	Lastacaft®		Pataday™		Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
Arm/Group Description	One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.		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.
All Cause Mortality
	Lastacaft®		Pataday™		Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Lastacaft®		Pataday™		Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Lastacaft®		Pataday™		Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/52 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.