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

Faes Farma

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Bilastine 0.2%; Drug: Bilastine 0.6%; Drug: Bilastine 0%; Drug: Bilastine 0.4%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03231969

BOFT-0117/DR-CAC

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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121 participants in 4 patient groups, including a placebo group

Bilastine 0.2%

Experimental group

Description:

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

Treatment:

Drug: Bilastine 0.2%

Bilastine 0.4%

Experimental group

Description:

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

Treatment:

Drug: Bilastine 0.4%

Bilastine 0.6%

Experimental group

Description:

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

Treatment:

Drug: Bilastine 0.6%

Bilastine 0%

Placebo Comparator group

Description:

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

Treatment:

Drug: Bilastine 0%