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

NCT03479307 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BOFT-0218/AC-CAC
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 6

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (3)

Bilastine Ophthalmic Solution 0.6%

EXPERIMENTAL

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%

Ketotifen Ophthalmic Solution 0.025% (Zaditen)

ACTIVE COMPARATOR

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)

Vehicle of Bilastine Ophthalmic Solution

PLACEBO COMPARATOR

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

Interventions

Bilastine Ophthalmic Solution 0.6% DRUG

1 drop in each eye at 2 separate times during an 8 day period.

Bilastine Ophthalmic Solution 0.6%

Ketotifen Ophthalmic Solution 0.025% (Zaditen) DRUG

1 drop in each eye at 2 separate times during an 8 day period.

Also known as: Zaditen

Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Vehicle of Bilastine Ophthalmic Solution DRUG

1 drop in each eye at 2 separate times during an 8 day period.

Vehicle of Bilastine Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faes Farma, S.A.: lead
• ORA, Inc.: collaborator

Study Sites (6)

Cornea Consultants of AZ

Phoenix, Arizona, 85032, United States

Location

East West Eye Institute

Torrance, California, 90505, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Apex Eye

Mason, Ohio, 45040, United States

Location

Philadelphia Eye Associates

Philadelphia, Pennsylvania, 19134, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

Related Publications (1)

• Gomes PJ, Ciolino JB, Arranz P, Hernandez G, Fernandez N. Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis. J Investig Allergol Clin Immunol. 2024 Jun 17;34(3):167-176. doi: 10.18176/jiaci.0894. Epub 2023 Feb 23.

  PMID: 36811846 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Ketotifen

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nieves Fernández, MD, PhD
• Organization: Faes Farma

nfernandez@faes.es

+34 94 481 83 00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: April 7, 2018
• Primary Completion: August 9, 2018
• Study Completion: August 10, 2018
• Last Updated: March 16, 2023
• Results First Posted: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)