Trial record 13 of 34 for:    Open Studies | "Eye Infections"

FST-100 in the Treatment of Acute Viral Conjunctivitis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014