FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: November 9, 2011
Last updated: September 22, 2015
Last verified: August 2014
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 Shire:

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
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


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 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01470664

United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Ora, Inc.
Noida, India, 201301
Sponsors and Collaborators
Study Director: Aron Shapiro ORA, Inc.
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01470664     History of Changes
Other Study ID Numbers: FST100-AVC-004 
Study First Received: November 9, 2011
Last Updated: September 22, 2015
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

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

ClinicalTrials.gov processed this record on May 26, 2016