FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

Shire

Status and phase: Completed; Phase 2

Conditions: Acute Adenoviral Conjunctivitis

Treatments: Drug: FST-100 Vehicle; Drug: FST-100; Drug: FST-100 (Component #1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470664

FST100-AVC-004

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 3 patient groups, including a placebo group

FST-100

Experimental group

Treatment:

Drug: FST-100

FST-100 (Component #1)

Experimental group

Treatment:

Drug: FST-100 (Component #1)

FST-100 Vehicle

Placebo Comparator group

Treatment:

Drug: FST-100 Vehicle