ClinicalTrials.Veeva

Menu

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

F

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

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%

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems