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FST-100 in the Treatment of Acute Viral Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01461954
First received: October 24, 2011
Last updated: September 14, 2015
Last verified: March 2015
October 24, 2011
September 14, 2015
May 2013
February 2014   (Final data collection date for primary outcome measure)
Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ]
Not Provided
Complete list of historical versions of study NCT01461954 on ClinicalTrials.gov Archive Site
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FST-100 in the Treatment of Acute Viral Conjunctivitis
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Viral Conjunctivitis
  • Drug: FST-100
    FST-100
  • Drug: FST-100 Vehicle
    FST-100 Vehicle
  • Experimental: FST-100
    Intervention: Drug: FST-100
  • Placebo Comparator: FST-100 Vehicle
    Intervention: Drug: FST-100 Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
March 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   United States
 
 
NCT01461954
FST100-AVC-005
No
Not Provided
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Shire
Shire
Not Provided
Study Director: Aron Shapiro ORA, Inc.
Shire
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP