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OpenTrials
Completed

NCT Number: NCT01461954

FST-100 in the Treatment of Acute Viral Conjunctivitis

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.

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Key information

Conditions

Acute Viral Conjunctivitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FST-100

Drug

FST-100

FST-100 Vehicle

Drug

FST-100 Vehicle

Primary outcomes

  1. Clinical resolution of acute viral conjunctivitis

    Time frame: 6-7 days

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Viral Conjunctivitis

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 28, 2011
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.