FST-100 in the Treatment of Acute Viral Conjunctivitis

Shire

Status and phase: Completed; Phase 2

Conditions: Acute Viral Conjunctivitis

Treatments: Drug: FST-100 Vehicle; Drug: FST-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461954

FST100-AVC-005

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 viral conjunctivitis. The study intends to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

FST-100

Experimental group

Treatment:

Drug: FST-100

FST-100 Vehicle

Placebo Comparator group

Treatment:

Drug: FST-100 Vehicle