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

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ClinicalTrials.gov Identifier: NCT03479307
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Faes Farma, S.A.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Bilastine Ophthalmic Solution 0.6% Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen) Drug: Vehicle of Bilastine Ophthalmic Solution Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Bilastine Ophthalmic Solution 0.6% Drug: Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.

Placebo Comparator: Ketotifen Ophthalmic Solution 0.025% (Zaditen) Drug: 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 Drug: Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.




Primary Outcome Measures :
  1. Ocular Itching [ Time Frame: Efficacy assessment period (Day 1 through Day 8) ]
    subjects will assess their ocular itching post-CAC on a 0-4 scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479307


Contacts
Contact: Nieves Fernandez, MD, PhD 94 481 83 00 nfernandez@faes.es

Locations
United States, Arizona
Cornea Consultants of AZ Recruiting
Phoenix, Arizona, United States, 85032
Contact: Caitlin Pearson    978-685-8900    cpearson@oraclinical.com   
United States, Ohio
Apex Eye Recruiting
Mason, Ohio, United States, 45040
Contact: Caitlin Pearson    978-685-8900    cpearson@oraclinical.com   
United States, Pennsylvania
Philadelphia Eye Associates Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Caitlin Pearson    978-685-8900    cpearson@oraclinical.com   
Sponsors and Collaborators
Faes Farma, S.A.
ORA, Inc.

Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT03479307     History of Changes
Other Study ID Numbers: BOFT-0218/AC-CAC
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Ketotifen
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents