A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
NCT ID: NCT03479307
Last Updated: 2023-03-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2018-04-07
2018-08-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
NCT03231969
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
NCT03489941
A Study of ADX-102 in Subjects With Allergic Conjunctivitis
NCT03012165
Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis
NCT00241319
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
NCT03320434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bilastine Ophthalmic Solution 0.6%
Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
Vehicle of Bilastine Ophthalmic Solution
Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.
Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bilastine Ophthalmic Solution 0.6%
1 drop in each eye at 2 separate times during an 8 day period.
Ketotifen Ophthalmic Solution 0.025% (Zaditen)
1 drop in each eye at 2 separate times during an 8 day period.
Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 2 separate times during an 8 day period.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ORA, Inc.
INDUSTRY
Faes Farma, S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cornea Consultants of AZ
Phoenix, Arizona, United States
East West Eye Institute
Torrance, California, United States
Andover Eye Associates
Andover, Massachusetts, United States
Apex Eye
Mason, Ohio, United States
Philadelphia Eye Associates
Philadelphia, Pennsylvania, United States
Total Eye Care, P.A.
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gomes PJ, Ciolino JB, Arranz P, Hernandez G, Fernandez N. Bilastine 0.6% Preservative-free Eye Drops: A Once-daily Treatment for Allergic Conjunctivitis. J Investig Allergol Clin Immunol. 2024 Jun 17;34(3):167-176. doi: 10.18176/jiaci.0894. Epub 2023 Feb 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BOFT-0218/AC-CAC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.