We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03479307
Recruitment Status : Completed
First Posted : March 27, 2018
Results First Posted : December 14, 2021
Last Update Posted : March 16, 2023
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Faes Farma, S.A.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 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 : April 7, 2018
Actual Primary Completion Date : August 9, 2018
Actual Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, Arizona
Cornea Consultants of AZ
Phoenix, Arizona, United States, 85032
United States, California
East West Eye Institute
Torrance, California, United States, 90505
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
United States, Ohio
Apex Eye
Mason, Ohio, United States, 45040
United States, Pennsylvania
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Faes Farma, S.A.
ORA, Inc.
  Study Documents (Full-Text)

Documents provided by Faes Farma, S.A.:
Study Protocol and Statistical Analysis Plan  [PDF] January 29, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Faes Farma, S.A.
ClinicalTrials.gov Identifier: NCT03479307    
Other Study ID Numbers: BOFT-0218/AC-CAC
First Posted: March 27, 2018    Key Record Dates
Results First Posted: December 14, 2021
Last Update Posted: March 16, 2023
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ketotifen
Pharmaceutical Solutions
Ophthalmic Solutions
 Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents