A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

Study Overview
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Brief Summary
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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.

Conditions
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Conjunctivitis, Allergic

Intervention / Treatment
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* Drug: alcaftadine 0.25% ophthalmic solution
* Drug: olopatadine 0.2% ophthalmic solution
* Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LASTACAFT® (alcaftadine 0.25%)<br>One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. | Drug: alcaftadine 0.25% ophthalmic solution<br>* One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.<br>* Other names: LASTACAFT®;|
| Active Comparator: Pataday™ (olopatadine 0.2%)<br>One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. | Drug: olopatadine 0.2% ophthalmic solution<br>* One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.<br>* Other names: Pataday™;|
| Placebo Comparator: Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)<br>One drop of placebo instilled in each eye at Day 0 and Day 14. | Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%<br>* One drop of placebo instilled in each eye at Day 0 and Day 14.<br>* Other names: Tears Naturale® II Artificial Tears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0 Hour 16 | 
| 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. | Day 14 Hour 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 14 Hour 24 | 
| 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. | Day 14 Hour 24 | 
| 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. | Day 14 Hour 24 | 
| 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. | Day 14 Hour 24 | 
| 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. | Day 14 Hour 24 | 
| 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. | Day 14 Hour 24 |