- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461954
FST-100 in the Treatment of Acute Viral Conjunctivitis
June 21, 2021 updated by: Shire
A Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Viral Conjunctivitis
This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute viral conjunctivitis.
The study intends to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil
- Hospital São Paulo/Federal University of São Paulo (UNIFESP)
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Massachusetts
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Andover, Massachusetts, United States, 01810
- Ora Clinical Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye
Exclusion Criteria:
- Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FST-100
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FST-100
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PLACEBO_COMPARATOR: FST-100 Vehicle
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FST-100 Vehicle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical resolution of acute viral conjunctivitis
Time Frame: 6-7 days
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6-7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 17, 2013
Primary Completion (ACTUAL)
March 10, 2014
Study Completion (ACTUAL)
March 10, 2014
Study Registration Dates
First Submitted
October 24, 2011
First Submitted That Met QC Criteria
October 26, 2011
First Posted (ESTIMATE)
October 28, 2011
Study Record Updates
Last Update Posted (ACTUAL)
June 24, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FST100-AVC-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Viral Conjunctivitis
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University of MiamiNovaBay Pharmaceuticals, Inc.Terminated
-
University of Campinas, BrazilCompletedViral ConjunctivitisBrazil
-
NicOxCompleted
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Mahidol UniversityCompleted
-
Adenovir Pharma ABTFS Trial Form SupportCompletedViral ConjunctivitisGermany, Poland, Sweden
-
IVIEW Therapeutics Inc.CompletedAcute Bacterial ConjunctivitisChina
Clinical Trials on FST-100 Vehicle
-
ShireCompletedAcute Adenoviral ConjunctivitisUnited States, India
-
Georgia State UniversityGeorgia Institute of TechnologyRecruitingCerebral PalsyUnited States
-
ShireTerminatedAcute Adenoviral ConjunctivitisUnited States
-
Pyramid BiosciencesCompletedPsoriasis | Healthy VolunteersUnited States
-
ShireTerminatedAdenoviral ConjunctivitisUnited States, Israel, France, India, Australia, Austria, Spain, Estonia, Hungary, Poland, South Africa, Canada, Germany, Italy, Peru, United Kingdom
-
ORA, Inc.Stuart Therapeutics, Inc.Recruiting
-
Critical Biologics CorporationCompletedBurns | Trauma | Infection | Low GelsolinHong Kong
-
Pyramid BiosciencesCompletedHealthy VolunteersUnited States
-
Stuart Therapeutics, Inc.ORA, Inc.Completed
-
Xequel Bio, Inc.CompletedScar | Breast Reconstruction | Scarring | MammoplastyUnited States