NCT01461954

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 17, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2014

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

10 months

First QC Date

October 24, 2011

Last Update Submit

June 21, 2021

Conditions

Acute Viral Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Clinical resolution of acute viral conjunctivitis

    6-7 days

Study Arms (2)

FST-100

EXPERIMENTAL
Drug: FST-100

FST-100 Vehicle

PLACEBO COMPARATOR
Drug: FST-100 Vehicle

Interventions

FST-100DRUG

FST-100

FST-100
FST-100 VehicleDRUG

FST-100 Vehicle

FST-100 Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye

You may not qualify if:

  • Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ora Clinical Site

Andover, Massachusetts, 01810, United States

Location

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

São Paulo, Brazil

Location

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 28, 2011

Study Start

May 17, 2013

Primary Completion

March 10, 2014

Study Completion

March 10, 2014

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

US(1)BR(1)