A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model
NCT ID: NCT03231969
Last Updated: 2023-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2017-07-20
2017-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Bilastine 0.2%
Bilastine Ophthalmic solution 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.4%
Bilastine Ophthalmic solution 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.6%
Bilastine Ophthalmic solution 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0%
Vehicle of Bilastine Ophthalmic Solution
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0%
1 drop in each eye at 3 separate times during a 25 day period.
Interventions
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Bilastine 0.2%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.4%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0.6%
1 drop in each eye at 3 separate times during a 25 day period.
Bilastine 0%
1 drop in each eye at 3 separate times during a 25 day period.
Eligibility Criteria
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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
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ORA, Inc.
INDUSTRY
Faes Farma, S.A.
INDUSTRY
Responsible Party
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Locations
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Ora Clinical Research Center
Andover, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BOFT-0117/DR-CAC
Identifier Type: -
Identifier Source: org_study_id
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