FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

Acute Adenoviral Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470664
• Other study ID #: FST100-AVC-004
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2012
• Est. completion date: May 23, 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 adenoviral conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 23, 2014
• Est. primary completion date: May 23, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a clinical diagnosis of suspected acute adenoviral 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 Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• FST-100
0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)
• FST-100 (Component #1)
0.6% PVP-Iodine ophthalmic solution alone
• FST-100 Vehicle
FST-100 Vehicle

Locations

Country	Name	City	State
India	Ora, Inc.	Noida
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoviral eradication and clinical resolution of the infection		6-7 days