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FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01470664
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Adenoviral Conjunctivitis Drug: FST-100 Drug: FST-100 (Component #1) Drug: FST-100 Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Adenoviral eradication and clinical resolution of the infection [ Time Frame: 6-7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470664


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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01470664     History of Changes
Other Study ID Numbers: FST100-AVC-004
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: August 2014

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