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FST-100 in the Treatment of Acute Viral Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461954
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Viral Conjunctivitis Drug: FST-100 Drug: FST-100 Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 17, 2013
Actual Primary Completion Date : March 10, 2014
Actual Study Completion Date : March 10, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

Arms and Interventions
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Arm Intervention/treatment
Experimental: FST-100 Drug: FST-100
FST-100
Placebo Comparator: FST-100 Vehicle Drug: FST-100 Vehicle
FST-100 Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461954


Locations
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United States, Massachusetts
Ora Clinical Site
Andover, Massachusetts, United States, 01810
Brazil
Hospital São Paulo/Federal University of São Paulo (UNIFESP)
São Paulo, Brazil
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01461954    
Other Study ID Numbers: FST100-AVC-005
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Conjunctivitis, Viral
Conjunctivitis
Conjunctival Diseases
Eye Diseases
 Eye Infections, Viral
Eye Infections
Infections
Virus Diseases