FST-100 in the Treatment of Acute Viral Conjunctivitis

NCT ID: NCT01461954

Last Updated: 2021-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-17

Study Completion Date

2014-03-10

Brief Summary

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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

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Conditions

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Acute Viral Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FST-100

Group Type EXPERIMENTAL

FST-100

Intervention Type DRUG

FST-100

FST-100 Vehicle

Group Type PLACEBO_COMPARATOR

FST-100 Vehicle

Intervention Type DRUG

FST-100 Vehicle

Interventions

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FST-100

FST-100

Intervention Type DRUG

FST-100 Vehicle

FST-100 Vehicle

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Ora Clinical Site

Andover, Massachusetts, United States

Site Status

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

São Paulo, , Brazil

Site Status

Countries

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United States Brazil

Other Identifiers

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FST100-AVC-005

Identifier Type: -

Identifier Source: org_study_id

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