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

NCT00770133 | Completed Phase 3 Results

• 1 other identifier: 572
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Ciliary Redness

  7, 15, and 20 minutes post challenge at 14 days

• Episcleral Redness

  7, 15, and 20 minutes post challenge at 14 days

• Chemosis

  7, 15, and 20 minutes post challenge at 14 days

• Eyelid Swelling

  7, 15, and 20 minutes post challenge at 14 days

• Percentage of Eyes With hTearing

  7, 15, and 20 minutes post challenge at 14 days

Study Arms (4)

Ketotifen/naphazoline

EXPERIMENTAL

Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Drug: Ketotifen/naphazoline

Vehicle

PLACEBO COMPARATOR

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

Naphazoline

ACTIVE COMPARATOR

Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Drug: Naphazoline

Ketotifen

ACTIVE COMPARATOR

Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Drug: Ketotifen

Interventions

Ketotifen/naphazoline DRUG

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

Ketotifen/naphazoline

Naphazoline DRUG

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

Naphazoline

Ketotifen DRUG

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

Ketotifen

Vehicle DRUG

One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Vehicle

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Ophthalmic Research Consultants, Inc.

North Andover, Massachusetts, 01845, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Ketotifen; Naphazoline

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

908-300-9920

Study Officials

• Laura Trusso

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 27, 2020
• Results First Posted: October 27, 2020

Record last verified: 2020-10

Locations

US (1)