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

Allergic Conjunctivitis Clinical Trial

Official title:

A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2, Dose Ranging Evaluation of the Effectiveness of Bilastine Ophthalmic Solution (0.2%, 0.4%, and 0.6%) Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231969
• Other study ID #: BOFT-0117/DR-CAC
• Status: Completed
• Phase: Phase 2
• Start date: July 20, 2017
• Est. completion date: October 11, 2017

Study information

• Verified date: October 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 (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 11, 2017
• Est. primary completion date: October 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key 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

Key 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 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
• Bilastine 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
• Bilastine 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
• Bilastine 0%
1 drop in each eye at 3 separate times during a 25 day period.

Locations

Country	Name	City	State
United States	Ora Clinical Research Center	Andover	Massachusetts

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 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).