A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

Study Overview
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Brief Summary
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A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Lastacaft ®
* Drug: Tears Naturale ® (Placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a positive history of ocular allergies and a positive skin test to protocol defined allergens Have a positive CAC reaction at Visit 1 Have a positive conjunctival inflammation score at Visit 1 Exclusion Criteria: May not use disallowed medications in specified washout period May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters May not have active ocular infection

Ages Eligible for Study
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Minimum Age: 18 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 ®<br>One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2 | Drug: Lastacaft ®<br> <br> |
| Placebo Comparator: Tears Naturale ®<br>One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2 | Drug: Tears Naturale ® (Placebo)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1 | Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score. | 1 hour (+30 minutes) post CAC on Day 1 | 
| Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2 | Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best [least inflammation] and 4 = worst [most inflammation]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score. | 1 hour (+30 minutes) post CAC on Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation) | CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score. | 15 minutes post-study medication instillation | 
| Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation) | CAC was performed 15 minutes after study medication instillation. Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]). The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score. | 15 minutes post-study medication instillation |