ClinicalTrials.gov
ClinicalTrials.gov Menu

FST-100 Ophthalmic Suspension in 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: NCT00941486
Recruitment Status : Terminated
First Posted : July 17, 2009
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The objective of this study is to evaluate the efficacy of FST-100 (0.1% dexamethasone) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.

Condition or disease Intervention/treatment Phase
Acute Adenoviral Conjunctivitis Drug: FST-100 (0.1% dexamethasone) Ophthalmic Suspension Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
Experimental: FST-100 (0.1% dexamethasone) Ophthalmic Suspension Drug: FST-100 (0.1% dexamethasone) Ophthalmic Suspension
A regimen of 2 drops 4 times a day while awake for 5 days.
Placebo Comparator: Vehicle Drug: Placebo
A regimen of 2 drops 4 times a day while awake for 5 days.



Primary Outcome Measures :
  1. Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.
  • Clinical suspicion of adenoviral etiology.
  • At least three (3) years of age.
  • Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent.
  • Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis:

    1. conjunctival injection/inflammation, and
    2. conjunctival discharge/exudates.

Exclusion Criteria:

  • Conjunctivitis longer than 7 days after initial ocular symptoms.
  • Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
  • Patients taking ocular anti-inflammatory medications on a chronic basis.
  • Active herpes ocular infection.
  • Known or suspected pregnancy.
  • Known allergy to PVP-I.
  • Known allergy to dexamethasone.
  • Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders".

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): NCT00941486


Locations
United States, California
Wolstan and Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Colorado
Colorado Eye Associates
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Eye Center
Hamden, Connecticut, United States, 06518
United States, Florida
The Center for Excellence in Eye
Miami, Florida, United States, 33176
Ocean Ophthalmology
North Miami Beach, Florida, United States, 33179
United States, Illinois
The Midwest Center for Sight
Des Plaines, Illinois, United States, 60016
Hoffman Estates, Illinois, United States, 60169
United States, Missouri
Silverstein Eye Centers
Kansas City, Missouri, United States, 64133
St. Johns Clinic
Springfield, Missouri, United States, 65804
United States, New York
Ophthalmic Consultants PC The New York Eye and Ear Infirmary
New York, New York, United States, 10003
Wantagh, New York, United States, 11793
United States, North Carolina
Charlotte, North Carolina, United States, 28204
United States, Ohio
Columbus Ophthalmology Associates
Columbus, Ohio, United States, 43213
Sponsors and Collaborators
Shire

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00941486     History of Changes
Other Study ID Numbers: FST100-AVC-02
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2012

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
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action