FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis

Phase 2

Terminated

• Conditions: Acute Adenoviral Conjunctivitis
• Interventions: Drug: FST-100 Ophthalmic Suspension; Drug: Placebo

• Registration Number: NCT00941486
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Primary Completion: 2010-06-30
• Study Completion: 2010-06-30
• Disposition First Submitted: 2012-09-05
• Disposition First Submitted QC: 2012-09-05
• Disposition First Posted: 2012-09-06
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-22
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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").

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FST-100 Ophthalmic Suspension	FST-100 Ophthalmic Suspension	FST-100 (PVP-I 0.4% and dexamethasone 0.1%)
Vehicle	Placebo	-

Primary Outcome Measures

Name	Time	Method
Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3.	1 year

Secondary Outcome Measures

Name	Time	Method
Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA.	1 year

Trial Locations

Locations (10)

The Center for Excellence in Eye; 🇺🇸 Miami, Florida, United States

Columbus Ophthalmology Associates; 🇺🇸 Columbus, Ohio, United States

Colorado Eye Associates; 🇺🇸 Colorado Springs, Colorado, United States

Wolstan and Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Eye Center; 🇺🇸 Hamden, Connecticut, United States

Ophthalmic Consultants PC The New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

The Midwest Center for Sight; 🇺🇸 Des Plaines, Illinois, United States

St. Johns Clinic; 🇺🇸 Springfield, Missouri, United States

Ocean Ophthalmology; 🇺🇸 North Miami Beach, Florida, United States

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States