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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 9, 2018

Interventions

  • Drug: Bilastine Ophthalmic Solution 0.6%
    • 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.
  • Drug: Vehicle of Bilastine Ophthalmic Solution
    • 1 drop in each eye at 2 separate times during an 8 day period.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Ocular Itching
    • Time Frame: The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Faes Farma, S.A.
  • Collaborator
    • ORA, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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