FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01470664
First received: November 9, 2011
Last updated: August 28, 2014
Last verified: August 2014
  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 ]

Enrollment: 176
Study Start Date: December 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
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: NCT01470664

Locations
United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
India
Ora, Inc.
Noida, India, 201301
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: August 28, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014