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NCT03231969 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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).
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