FST-100 in the Treatment of Acute Viral Conjunctivitis

This study is currently recruiting participants.
Verified June 2013 by Foresight Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01461954
First received: October 24, 2011
Last updated: June 28, 2013
Last verified: June 2013

October 24, 2011
June 28, 2013
May 2013
December 2013   (final data collection date for primary outcome measure)
Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01461954 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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 (Subject, Caregiver, 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.
 
Recruiting
132
December 2013
December 2013   (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
Both
18 Years and older
No
Contact: Ora Inc. 978-685-8900
United States,   Brazil
 
NCT01461954
FST100-AVC-005
No
Foresight Biotherapeutics
Foresight Biotherapeutics
Not Provided
Study Director: Aron Shapiro ORA, Inc.
Foresight Biotherapeutics
June 2013

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