A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

Faes Farma

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Drug: Vehicle of Bilastine Ophthalmic Solution; Drug: Bilastine Ophthalmic Solution 0.6%; Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03479307

BOFT-0218/AC-CAC

Details and patient eligibility

About

To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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: Double Blind

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228 participants in 3 patient groups, including a placebo group

Bilastine Ophthalmic Solution 0.6%

Experimental group

Description:

Bilastine Ophthalmic Solution 0.6% 1 drop in each eye at 2 separate times during an 8 day period.

Treatment:

Drug: Bilastine Ophthalmic Solution 0.6%

Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Active Comparator group

Description:

Ketotifen Ophthalmic Solution 0.025% (Zaditen) 1 drop in each eye at 2 separate times during an 8 day period.

Treatment:

Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)

Vehicle of Bilastine Ophthalmic Solution

Placebo Comparator group

Description:

Vehicle of Bilastine Ophthalmic Solution 1 drop in each eye at 2 separate times during an 8 day period.

Treatment:

Drug: Vehicle of Bilastine Ophthalmic Solution