FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis
NCT ID: NCT00941486
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2009-06-30
2010-06-30
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
DOUBLE
Study Groups
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FST-100 Ophthalmic Suspension
FST-100 (PVP-I 0.4% and dexamethasone 0.1%)
FST-100 Ophthalmic Suspension
FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
Vehicle
Placebo
A regimen of 2 drops 4 times a day while awake for 5 days.
Interventions
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FST-100 Ophthalmic Suspension
FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
Placebo
A regimen of 2 drops 4 times a day while awake for 5 days.
Eligibility Criteria
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Inclusion Criteria
* Clinical suspicion of adenoviral etiology.
* At least three (3) years of age.
* Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent.
* Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis:
1. conjunctival injection/inflammation, and
2. conjunctival discharge/exudates.
Exclusion Criteria
* Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
* Patients taking ocular anti-inflammatory medications on a chronic basis.
* Active herpes ocular infection.
* Known or suspected pregnancy.
* Known allergy to PVP-I.
* Known allergy to dexamethasone.
* Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").
3 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Wolstan and Goldberg Eye Associates
Torrance, California, United States
Colorado Eye Associates
Colorado Springs, Colorado, United States
Eye Center
Hamden, Connecticut, United States
The Center for Excellence in Eye
Miami, Florida, United States
Ocean Ophthalmology
North Miami Beach, Florida, United States
The Midwest Center for Sight
Des Plaines, Illinois, United States
Hoffman Estates, Illinois, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
St. Johns Clinic
Springfield, Missouri, United States
Ophthalmic Consultants PC The New York Eye and Ear Infirmary
New York, New York, United States
Wantagh, New York, United States
Charlotte, North Carolina, United States
Columbus Ophthalmology Associates
Columbus, Ohio, United States
Countries
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Other Identifiers
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FST100-AVC-02
Identifier Type: -
Identifier Source: org_study_id
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