Phase 3
Completed N=228
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Source: ClinicalTrials.gov NCT03479307 ↗Enrolled (actual)
228
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Ocular Itching — 1.609; 1.886; 2.219; 1.750 units on a scale — p=< 0.0001
◆ Published Evidence
Emerging
17citations · ~9 / year
Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis.
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.
Linked Publications
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Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
1.609; 1.886; 2.219; 1.750; 1.919; 2.490 | < 0.0001 sig |
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) and the linked publication. 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. Informational only — not medical advice.