FST-100 in the Treatment of Acute Viral Conjunctivitis

Acute Viral Conjunctivitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461954
• Other study ID #: FST100-AVC-005
• Status: Completed
• Phase: Phase 2
• Start date: May 17, 2013
• Est. completion date: March 10, 2014

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 10, 2014
• Est. primary completion date: March 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Viral Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Viral

Intervention

Drug:
• FST-100
FST-100
• FST-100 Vehicle
FST-100 Vehicle

Locations

Country	Name	City	State
Brazil	Hospital São Paulo/Federal University of São Paulo (UNIFESP)	São Paulo
United States	Ora Clinical Site	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical resolution of acute viral conjunctivitis		6-7 days