FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

Acute Adenoviral Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00941486
• Other study ID #: FST100-AVC-02
• Status: Terminated
• Phase: Phase 2
• Start date: June 30, 2009
• Est. completion date: June 30, 2010

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 30, 2010
• Est. primary completion date: June 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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").

Related Conditions & MeSH terms

• Acute Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• FST-100 Ophthalmic Suspension
FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
• Placebo
A regimen of 2 drops 4 times a day while awake for 5 days.

Locations

Country	Name	City	State
United States	Colorado Eye Associates	Colorado Springs	Colorado
United States	Columbus Ophthalmology Associates	Columbus	Ohio
United States	The Midwest Center for Sight	Des Plaines	Illinois
United States	Eye Center	Hamden	Connecticut
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	The Center for Excellence in Eye	Miami	Florida
United States	Ophthalmic Consultants PC The New York Eye and Ear Infirmary	New York	New York
United States	Ocean Ophthalmology	North Miami Beach	Florida
United States	St. Johns Clinic	Springfield	Missouri
United States	Wolstan and Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.		1 year
Secondary	Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.		1 year