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

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Bilastine 0.2%; Drug: Bilastine 0.6%; Drug: Bilastine 0%; Drug: Bilastine 0.4%

• Registration Number: NCT03231969
• Lead Sponsor: Faes Farma, S.A.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-20
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Primary Completion: 2017-10-11
• Study Completion: 2017-10-11
• Disposition First Submitted: 2018-10-25
• Results First Submitted: 2021-03-09
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-28
• Disposition First Submitted QC: 2021-10-28
• Results First Posted: 2021-11-24
• Disposition First Posted: 2021-11-24
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilastine 0.2%	Bilastine 0.2%	Bilastine Ophthalmic solution 0.2% 1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.6%	Bilastine 0.6%	Bilastine Ophthalmic solution 0.6% 1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0%	Bilastine 0%	Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.4%	Bilastine 0.4%	Bilastine Ophthalmic solution 0.4% 1 drop in each eye at 3 separate times during a 25 day period.

Primary Outcome Measures

Name	Time	Method
Ocular Itching	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).	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.

Trial Locations

Locations (1)

Ora Clinical Research Center; 🇺🇸 Andover, Massachusetts, United States