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
  Purpose

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 Intervention Phase
Acute Viral Conjunctivitis
Drug: FST-100
Drug: FST-100 Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Foresight Biotherapeutics:

Primary Outcome Measures:
  • Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: May 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FST-100 Drug: FST-100
FST-100
Placebo Comparator: FST-100 Vehicle Drug: FST-100 Vehicle
FST-100 Vehicle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461954

Contacts
Contact: Ora Inc. 978-685-8900

Locations
United States, Massachusetts
Ora Clinical Site Not yet recruiting
Please Contact Ora Call Center for Trial Locations, Massachusetts, United States
Contact: Ora, Inc.    978-685-8900      
Brazil
Ora Clinical Site Recruiting
Please Contact Ora Call Center for Trial Locations, Brazil
Contact: Ora, Inc.    978-685-8900      
Sponsors and Collaborators
Foresight Biotherapeutics
Investigators
Study Director: Aron Shapiro ORA, Inc.
  More Information

No publications provided

Responsible Party: Foresight Biotherapeutics
ClinicalTrials.gov Identifier: NCT01461954     History of Changes
Other Study ID Numbers: FST100-AVC-005
Study First Received: October 24, 2011
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration
Brazil: Brazilian Health Surveillance Agency(ANVISA)

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
Eye Infections, Viral
Virus Diseases
Eye Infections

ClinicalTrials.gov processed this record on April 17, 2014