Phase 2
N=121
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT03231969 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Ocular Itching — 1.908; 1.925; 1.177; 2.758 units on a scale — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bilastine 0.2% (Drug); Bilastine 0.4% (Drug); Bilastine 0.6% (Drug); Bilastine 0% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Faes Farma, S.A.
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
1.908; 1.925; 1.177; 2.758; 2.075; 2.117 | 0.0002 sig |
Summary
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03231969). 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.