Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

Bausch & Lomb Incorporated141 enrolled

Overview

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

141

Conditions

Allergic Conjunctivitis

Interventions

Ketotifen/naphazolineDRUG

One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.

NaphazolineDRUG

One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.

KetotifenDRUG

One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months. * Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart. * Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1. * Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2. Exclusion Criteria: * Known contraindications or sensitivities to the study medication or its components. * Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. * Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Locations (1)

Ophthalmic Research Consultants, Inc.

North Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Ocular Itching

Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub

Time frame: 3, 5, and 7 minutes post challenge at 14 days

Conjunctival Redness

Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

Time frame: 7, 15, and 20 minutes post challenge at 14 days

Secondary Outcomes

Ciliary Redness

Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

Time frame: 7, 15, and 20 minutes post challenge at 14 days

Episcleral Redness

Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

Time frame: 7, 15, and 20 minutes post challenge at 14 days

Chemosis

Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

Time frame: 7, 15, and 20 minutes post challenge at 14 days

Eyelid Swelling

Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe.

Data from ClinicalTrials.gov

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