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

Description

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 Start Date

February, 26 2018

Estimated Completion Date

August 2018

Interventions

  • Drug: Bilastine Ophthalmic Solution 0.6%
  • Drug: Vehicle of Bilastine Ophthalmic Solution
  • Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Study ID

Faes Farma, S.A. -- BOFT-0218/AC-CAC

Status

Unknown

Trial ID

NCT03479307

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

225

Sponsor

Faes Farma, S.A.

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

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Philadelphia Eye Associates - Philadelphia, Pennsylvania 129.6 miles Caitlin Pearson 978-685-8900 cpearson@oraclinical.com
Apex Eye - Mason, Ohio 598.4 miles Caitlin Pearson 978-685-8900 cpearson@oraclinical.com
Cornea Consultants of AZ - Phoenix, Arizona 2,176.8 miles Caitlin Pearson 978-685-8900 cpearson@oraclinical.com

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