FST-100 in the Treatment of Acute Viral Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 24, 2011
Last updated: September 14, 2015
Last verified: March 2015
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 Shire:

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

Enrollment: 132
Study Start Date: May 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FST-100 Drug: FST-100
Placebo Comparator: FST-100 Vehicle Drug: FST-100 Vehicle
FST-100 Vehicle


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01461954

United States, Massachusetts
Ora Clinical Site
Please Contact Ora Call Center for Trial Locations, Massachusetts, United States
Ora Clinical Site
Please Contact Ora Call Center for Trial Locations, Brazil
Sponsors and Collaborators
Study Director: Aron Shapiro ORA, Inc.
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01461954     History of Changes
Other Study ID Numbers: FST100-AVC-005
Study First Received: October 24, 2011
Last Updated: September 14, 2015
Health Authority: United States: Food and Drug Administration
Brazil: Brazilian Health Surveillance Agency(ANVISA)

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

ClinicalTrials.gov processed this record on November 30, 2015