Clinical trial NCT00941486: FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis
Official title: A Randomized, Masked, Vehicle-controlled Clinical Trial to Assess the Safety and Efficacy of PVP-I (0.4%)/Dexamethasone (0.1%) Ophthalmic Suspension (Foresight Biotherapeutics, Inc) in the Treatment of Acute Adenoviral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Adenoviral Conjunctivitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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").

Primary outcomes:
measure: Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.
timeFrame: 1 year
Secondary outcomes:
measure: Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.
timeFrame: 1 year
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan and Goldberg Eye Associates
state: California
city: Colorado Springs
country: United States
facility: Colorado Eye Associates
state: Colorado
city: Hamden
country: United States
facility: Eye Center
state: Connecticut
city: Miami
country: United States
facility: The Center for Excellence in Eye
state: Florida
city: North Miami Beach
country: United States
facility: Ocean Ophthalmology
state: Florida
city: Des Plaines
country: United States
facility: The Midwest Center for Sight
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Springfield
country: United States
facility: St. Johns Clinic
state: Missouri
city: New York
country: United States
facility: Ophthalmic Consultants PC The New York Eye and Ear Infirmary
state: New York
city: Wantagh
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
facility: Columbus Ophthalmology Associates
state: Ohio
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: