FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

This study is currently recruiting participants.
Verified June 2013 by Foresight Biotherapeutics
Sponsor:
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01470664
First received: November 9, 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 adenoviral conjunctivitis.


Condition Intervention Phase
Acute Adenoviral Conjunctivitis
Drug: FST-100
Drug: FST-100 (Component #1)
Drug: FST-100 Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Adenoviral Conjunctivitis

Resource links provided by NLM:


Further study details as provided by Foresight Biotherapeutics:

Primary Outcome Measures:
  • Adenoviral eradication and clinical resolution of the infection [ Time Frame: 6-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: December 2012
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
Experimental: FST-100 (Component #1) Drug: FST-100 (Component #1)
FST-100 (Component #1)
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 adenoviral 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: NCT01470664

Contacts
Contact: Ora, Inc. 978-685-8900

Locations
United States, Massachusetts
Ora, Inc. Recruiting
Andover, Massachusetts, United States, 01810
Contact: Please Contact Ora for Trial Locations    978-685-8900      
India
Ora, Inc. Recruiting
Noida, India, 201301
Contact: Please Contact Ora for Trial Locations    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: NCT01470664     History of Changes
Other Study ID Numbers: FST100-AVC-004
Study First Received: November 9, 2011
Last Updated: June 28, 2013
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Eye Infections, Bacterial
Eye Infections
Conjunctivitis
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Infection

ClinicalTrials.gov processed this record on April 15, 2014