FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

A Proof-of-Concept, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Adenoviral Conjunctivitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470664

Enrollment

176

Registered

2011-11-11

Start date

2012-12-17

Completion date

2014-05-23

Last updated

2021-06-25

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

Conditions

Acute Adenoviral 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 adenoviral conjunctivitis.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

India, United States

Outcome results

None listed

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