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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479307
• Other study ID #: BOFT-0218/AC-CAC
• Status: Completed
• Phase: Phase 3
• Start date: April 7, 2018
• Est. completion date: August 10, 2018

Study information

• Verified date: November 2021
• Source: Faes Farma, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: August 10, 2018
• Est. primary completion date: August 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
• Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
• Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Apex Eye	Mason	Ohio
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania
United States	Cornea Consultants of AZ	Phoenix	Arizona
United States	East West Eye Institute	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Faes Farma, S.A.	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).