FST-100 in the Treatment of Acute Viral Conjunctivitis

This study is not yet open for participant recruitment.

Verified August 2012 by Foresight Biotherapeutics

Sponsor:

Information provided by (Responsible Party):

Foresight Biotherapeutics

ClinicalTrials.gov Identifier:

NCT01461954

First received: October 24, 2011

Last updated: August 21, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 24, 2011

Last Updated Date

August 21, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01461954 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

FST-100 in the Treatment of Acute Viral Conjunctivitis

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Viral Conjunctivitis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: FST-100
Intervention: Drug: FST-100
Placebo Comparator: FST-100 Vehicle
Intervention: Drug: FST-100 Vehicle

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

132

Estimated Completion Date

May 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ora Inc.

978-685-8900

Location Countries ^ICMJE

United States, Brazil

Administrative Information

NCT Number ^ICMJE

NCT01461954

Other Study ID Numbers ^ICMJE

FST100-AVC-005

Has Data Monitoring Committee

Not Provided

Responsible Party

Foresight Biotherapeutics

Study Sponsor ^ICMJE

Foresight Biotherapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Aron Shapiro

ORA, Inc.

Information Provided By

Foresight Biotherapeutics

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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