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

A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.

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 Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Ketotifen/naphazoline; Drug: Vehicle; Drug: Naphazoline; Drug: Ketotifen

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • North Andover, Massachusetts, United States, 01845
      • Ophthalmic Research Consultants, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketotifen/naphazoline; Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Ketotifen/naphazoline; One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
Placebo Comparator: Vehicle; Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Vehicle; One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Active Comparator: Naphazoline; Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Naphazoline; One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
Active Comparator: Ketotifen; Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.	Drug: Ketotifen; One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	7, 15, and 20 minutes post challenge at 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With hTearing	Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.	7, 15, and 20 minutes post challenge at 14 days
Percentage of Eyes With Ocular Mucus Discharge	Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.	7, 15, and 20 minutes post challenge at 14 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Laura Trusso, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 8, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (Estimate): October 9, 2008

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Vasoconstrictor Agents; Nasal Decongestants; Ketotifen; Naphazoline
• Other Study ID Numbers: 572