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FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00941486
First received: July 15, 2009
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Acute Adenoviral Conjunctivitis
Drug: FST-100 (0.1% dexamethasone) Ophthalmic Suspension
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Foresight Biotherapeutics:

Primary Outcome Measures:
  • Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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".
  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: 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
Foresight Biotherapeutics
  More Information

No publications provided

Responsible Party: Foresight Biotherapeutics
ClinicalTrials.gov Identifier: NCT00941486     History of Changes
Other Study ID Numbers: FST100-AVC-02
Study First Received: July 15, 2009
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014