A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

A Multi-Center, Double-Masked, Randomized, Vehicle- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Bilastine Ophthalmic Solution 0.6% Compared to Vehicle and Zaditen (Ketotifen Ophthalmic Solution 0.025%) for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Bilastine Ophthalmic Solution 0.6%; Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen); Drug: Vehicle of Bilastine Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea Consultants of AZ
  • California
    • Torrance, California, United States, 90505
      • East West Eye Institute
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • Ohio
    • Mason, Ohio, United States, 45040
      • Apex Eye
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • Philadelphia Eye Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• be at least 18 years old
• be willing and able to avoid all disallowed medications and contact lenses
• must have a pregnancy test if of childbearing potential
• must be able to read an eye chart from 10 feet away

Exclusion Criteria:

• must not have any allergies to the study medications
• must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
• must not have used immunotherapy in the last 2 years
• must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilastine Ophthalmic Solution 0.6%; Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.	Drug: Bilastine Ophthalmic Solution 0.6%; 1 drop in each eye at 2 separate times during an 8 day period.
Active Comparator: Ketotifen Ophthalmic Solution 0.025% (Zaditen); Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period.	Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen); 1 drop in each eye at 2 separate times during an 8 day period.; Other Names: Zaditen
Placebo Comparator: Vehicle of Bilastine Ophthalmic Solution; Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period.	Drug: Vehicle of Bilastine Ophthalmic Solution; 1 drop in each eye at 2 separate times during an 8 day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Itching	The primary efficacy measure was ocular itching evaluated by the subject at 3 (± 1), 5 (±1), and 7 (± 1) minutes post-CAC (Conjunctival Allergen Challenge) at Visits 4b and 5, using a 0 to 4 Ora Calibra scale (0 = None , 4= An incapacitating itch with an irresistible urge to rub).	The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).

Collaborators and Investigators

• Sponsor: Faes Farma, S.A.
• Collaborators: ORA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2018
• Primary Completion (Actual): August 9, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: November 1, 2021

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; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Ophthalmic Solutions; Pharmaceutical Solutions; Ketotifen
• Other Study ID Numbers: BOFT-0218/AC-CAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No