FST-100 in the Treatment of Acute Viral Conjunctivitis

Phase 2CompletedNCT01461954

Shire132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

132

Conditions

Acute Viral Conjunctivitis

Interventions

FST-100DRUG

FST-100

FST-100 VehicleDRUG

FST-100 Vehicle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Ora Clinical Site

Andover, Massachusetts, United States

Hospital São Paulo/Federal University of São Paulo (UNIFESP)

São Paulo, Brazil

Outcomes

Primary Outcomes

Clinical resolution of acute viral conjunctivitis

Time frame: 6-7 days

Data from ClinicalTrials.gov

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