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CompletedNCT01470664Updated Jun 25, 2021

FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

A Phase 2 interventional study of FST-100 and FST-100 (Component #1) in Acute Adenoviral Conjunctivitis, sponsored by Shire. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-25.

Sponsored by Shire · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
176
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 adenoviral conjunctivitis.

02

Conditions studied

  • Acute Adenoviral 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 176 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 adenoviral 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
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
176 participants (actual)

Study arms

  • Experimental
    FST-100

    Drug: FST-100

  • Experimental
    FST-100 (Component #1)

    Drug: FST-100 (Component #1)

  • Placebo comparator
    FST-100 Vehicle

    Drug: FST-100 Vehicle

Interventions

  • DrugFST-100

    0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)

  • DrugFST-100 (Component #1)

    0.6% PVP-Iodine ophthalmic solution alone

  • DrugFST-100 Vehicle

    FST-100 Vehicle

06

What researchers measure

Primary outcomes

  1. Adenoviral eradication and clinical resolution of the infection

    Time frame: 6-7 days

07

Study locations

2 sites
  • Ora, Inc.
    Andover, Massachusetts 01810, United States
  • Ora, Inc.
    Noida, 201301, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 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
NCT01470664
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Nov 11, 2011
Start date
Dec 17, 2012
Primary completion
May 23, 2014
Completion
May 23, 2014
Last update
Jun 25, 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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