FST-100 in the Treatment of Acute Viral Conjunctivitis

Phase 2

Completed

• Conditions: Acute Viral Conjunctivitis
• Interventions: Drug: FST-100; Drug: FST-100 Vehicle

• Registration Number: NCT01461954
• Lead Sponsor: Shire

Brief Summary

This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Study Start: 2013-05-17
• Primary Completion: 2014-03-10
• Study Completion: 2014-03-10
• Disposition First Submitted: 2015-03-25
• Disposition First Submitted QC: 2015-03-25
• Disposition First Posted: 2015-04-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye

Exclusion Criteria

• Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FST-100	FST-100	-
FST-100 Vehicle	FST-100 Vehicle	-

Primary Outcome Measures

Name	Time	Method
Clinical resolution of acute viral conjunctivitis	6-7 days

Trial Locations

Locations (2)

Ora Clinical Site; 🇺🇸 Andover, Massachusetts, United States

Hospital São Paulo/Federal University of São Paulo (UNIFESP); 🇧🇷 São Paulo, Brazil