A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

NCT03231969 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BOFT-0117/DR-CAC
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle 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 post-CAC (Conjunctival Allergen Challenge) at Visits 4b, 5b, and 6, using a 0 to 4 Ora Calibra scale: 0 = none (normal, no itching), 4 = incapacitating itch.

  The outcome measure was assessed at Visit 4b (Day 1, 16h post treatment), Visit 5b (Day 15 ±3, 8h post treatment), and Visit 6 (Day 22 ±3, 15 minutes post treatment).

Study Arms (4)

Bilastine 0.2%

EXPERIMENTAL

Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period.

Drug: Bilastine 0.2%

Bilastine 0.4%

EXPERIMENTAL

Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period.

Drug: Bilastine 0.4%

Bilastine 0.6%

EXPERIMENTAL

Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period.

Drug: Bilastine 0.6%

Bilastine 0%

PLACEBO COMPARATOR

Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period.

Drug: Bilastine 0%

Interventions

Bilastine 0.2% DRUG

1 drop in each eye at 3 separate times during a 25 day period.

Bilastine 0.2%

Bilastine 0.4% DRUG

1 drop in each eye at 3 separate times during a 25 day period.

Bilastine 0.4%

Bilastine 0.6% DRUG

1 drop in each eye at 3 separate times during a 25 day period.

Bilastine 0.6%

Bilastine 0% DRUG

1 drop in each eye at 3 separate times during a 25 day period.

Bilastine 0%

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 (1)

Ora Clinical Research Center

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 27, 2017
• Study Start: July 20, 2017
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: March 16, 2023
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)