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CompletedNCT01461954Updated Jun 24, 2021

FST-100 in the Treatment of Acute Viral Conjunctivitis

A Phase 2 interventional study of FST-100 and FST-100 Vehicle in Acute Viral Conjunctivitis, sponsored by Shire. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Shire · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Acute Viral Conjunctivitis

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03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 132 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    FST-100

    Drug: FST-100

  • Placebo comparator
    FST-100 Vehicle

    Drug: FST-100 Vehicle

Interventions

  • DrugFST-100

    FST-100

  • DrugFST-100 Vehicle

    FST-100 Vehicle

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What researchers measure

Primary outcomes

  1. Clinical resolution of acute viral conjunctivitis

    Time frame: 6-7 days

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Study locations

2 sites
  • Ora Clinical Site
    Andover, Massachusetts 01810, United States
  • Hospital São Paulo/Federal University of São Paulo (UNIFESP)
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01461954
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Oct 28, 2011
Start date
May 17, 2013
Primary completion
Mar 10, 2014
Completion
Mar 10, 2014
Last update
Jun 24, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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