FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

Shire176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

176

Conditions

Acute Adenoviral Conjunctivitis

Interventions

FST-100DRUG

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

FST-100 (Component #1)DRUG

0.6% PVP-Iodine ophthalmic solution alone

FST-100 VehicleDRUG

FST-100 Vehicle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Ora, Inc.

Andover, Massachusetts, United States

Ora, Inc.

Noida, India

Outcomes

Primary Outcomes

Adenoviral eradication and clinical resolution of the infection

Time frame: 6-7 days

Data from ClinicalTrials.gov

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