FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

Phase 2

Completed

• Conditions: Acute Adenoviral Conjunctivitis
• Interventions: Drug: FST-100 (Component #1); Drug: FST-100 Vehicle; Drug: FST-100

• Registration Number: NCT01470664
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Study Start: 2012-12-17
• Primary Completion: 2014-05-23
• Study Completion: 2014-05-23
• Disposition First Submitted: 2015-09-03
• Disposition First Submitted QC: 2015-09-03
• Disposition First Posted: 2015-09-18
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FST-100 (Component #1)	FST-100 (Component #1)	-
FST-100 Vehicle	FST-100 Vehicle	-
FST-100	FST-100	-

Primary Outcome Measures

Name	Time	Method
Adenoviral eradication and clinical resolution of the infection	6-7 days

Trial Locations

Locations (1)

Ora, Inc.; 🇮🇳 Noida, India