FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Adenoviral Conjunctivitis

In brief

The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.

Key facts

Study ID

NCT00941486

Run by

Shire

People needed

30

Starts

2009-06-30

Expected to finish

2010-06-30

Last updated by the study team

2021-08-24

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• conjunctival injection/inflammation, and
• conjunctival discharge/exudates.

You may not qualify if…

• 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").

Where it is running

• Wolstan and Goldberg Eye Associates — Torrance, California, United States
• Colorado Eye Associates — Colorado Springs, Colorado, United States
• Eye Center — Hamden, Connecticut, United States
• The Center for Excellence in Eye — Miami, Florida, United States
• Ocean Ophthalmology — North Miami Beach, Florida, United States
• The Midwest Center for Sight — Des Plaines, Illinois, United States
• Study site — Hoffman Estates, Illinois, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• St. Johns Clinic — Springfield, Missouri, United States
• Ophthalmic Consultants PC The New York Eye and Ear Infirmary — New York, New York, United States
• Study site — Wantagh, New York, United States
• Study site — Charlotte, North Carolina, United States
• Columbus Ophthalmology Associates — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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