Phase 3
N=228
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT03479307 ↗Enrolled (actual)
228
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Ocular Itching — 1.609; 1.886; 2.219; 1.750 units on a scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bilastine Ophthalmic Solution 0.6% (Drug); Ketotifen Ophthalmic Solution 0.025% (Zaditen) (Drug); Vehicle of Bilastine Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Faes Farma, S.A.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
1.609; 1.886; 2.219; 1.750; 1.919; 2.490 | < 0.0001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03479307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.