NCT02308501 - A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

25

Conditions

Allergic Conjunctivitis

Interventions

Lastacaft ®DRUG

Tears Naturale ® (Placebo)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 hour (+30 minutes) post CAC on Day 2

Secondary Outcomes

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.

Time frame: 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.