FST-100 in the Treatment of Acute Adenoviral Conjunctivitis

June 23, 2021 updated by: Shire

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Noida, India, 201301
        • ORA, Inc.
  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • ORA, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FST-100
Drug: FST-100
0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)
EXPERIMENTAL: FST-100 (Component #1)
Drug: FST-100 (Component #1)
0.6% PVP-Iodine ophthalmic solution alone
PLACEBO_COMPARATOR: FST-100 Vehicle
Drug: FST-100 Vehicle
FST-100 Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adenoviral eradication and clinical resolution of the infection
Time Frame: 6-7 days
6-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 17, 2012

Primary Completion (ACTUAL)

May 23, 2014

Study Completion (ACTUAL)

May 23, 2014

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (ESTIMATE)

November 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 23, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FST100-AVC-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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