FST-100 in the Treatment of Acute Adenoviral Conjunctivitis | NCT01470664

Studies
FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

NCT01470664

Sponsor

Shire

Status

Completed

Last Update Posted

Jun 25, 2021Actual

Enrollment

176Actual

Phase

Phase 2

Conditions

Acute Adenoviral Conjunctivitis

Interventions

FST-100
FST-100 (Component #1)
FST-100 Vehicle

Countries

United States
India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2012Actual

Primary Completion Date

May 23, 2014Actual

Completion Date

May 23, 2014Actual

First Submitted Date

Nov 9, 2011

First Submission Date that Met QC Criteria

Nov 10, 2011

First Posted Date

Nov 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 3, 2015

Certification/Extension First Submitted that Passed QC Review

Sep 3, 2015

Certification/Extension First Posted Date

Sep 18, 2015Estimated

Last Update Submitted Date

Jun 23, 2021

Last Update Posted Date

Jun 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 adenoviral conjunctivitis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
FST-100	Experimental	Drug: FST-100
FST-100 (Component #1)	Experimental	Drug: FST-100 (Component #1)
FST-100 Vehicle	Placebo Comparator	Drug: FST-100 Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FST-100	Drug	0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)	FST-100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adenoviral eradication and clinical resolution of the infection		6-7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Takeda	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ora, Inc.		Andover	Massachusetts	01810	United States
Ora, Inc.