Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

ORA, Inc.11 enrolled

Overview

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, Prednisolone, assessed by the following measures: * Ocular itching * Conjunctival redness

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5. * Prednisolone phosphate * Tears Naturale II Ophthalmic Solution (Placebo) Duration: Approximately 19 days Controls: Artificial Tears (Tears Naturale® II)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Prednisolone Sodium Phosphate Ophthalmic Solution 1%DRUG

One drop in each eye, four times/day for 8 days.

Tears Naturale II Ophthalmic SolutionDRUG

one drop in each eye, four times/ day (QID) for 8 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 18 years of age \& either sex, any race * Willing and able to follow all instructions * Positive history of ocular allergies * Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge Exclusion Criteria: * Have planned surgery during trial period * Female currently pregnant, planning a pregnancy or lactating * Use of disallowed medications * Have ocular infections, or ocular conditions that could affect study parameters * Have moderate to severe dry eye * Have used an investigational drug or device within 30 days of start of study * Female that is currently pregnant, planning a pregnancy or lactating

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Ocular Itching Change From Baseline to Day 11

Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).

Time frame: 5 minutes post-CAC

Secondary Outcomes

Conjunctival Redness Change From Baseline to Day 11

Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)

Time frame: 7 Minutes post-CAC

Episcleral Redness Change From Baseline to Day 6

Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).

Time frame: 7 minutes post-CAC

Ciliary Redness Change From Baseline to Day 6

Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).

Time frame: 7 minutes post-CAC

Data from ClinicalTrials.gov

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