Skip to content

FST-100 in the Treatment of Acute Viral Conjunctivitis

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01461954
Enrollment
132
Registered
2011-10-28
Start date
2013-05-17
Completion date
2014-03-10
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

FST-100

FST-100 Vehicle

Sponsors

Shire
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical resolution of acute viral conjunctivitis6-7 days

Countries

Brazil, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026