Back to resultsFST-100 in the Treatment of Acute Adenoviral Conjunctivitis
Primary Purpose
Acute Adenoviral Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FST-100
FST-100 (Component #1)
FST-100 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Acute Adenoviral Conjunctivitis
Eligibility Criteria
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.
Sites / Locations
- Ora, Inc.
- Ora, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
FST-100
FST-100 (Component #1)
FST-100 Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Adenoviral eradication and clinical resolution of the infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01470664
Brief Title
FST-100 in the Treatment of Acute Adenoviral Conjunctivitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2012 (Actual)
Primary Completion Date
May 23, 2014 (Actual)
Study Completion Date
May 23, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Adenoviral Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FST-100
Arm Type
Experimental
Arm Title
FST-100 (Component #1)
Arm Type
Experimental
Arm Title
FST-100 Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
FST-100
Intervention Description
0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)
Intervention Type
Drug
Intervention Name(s)
FST-100 (Component #1)
Intervention Description
0.6% PVP-Iodine ophthalmic solution alone
Intervention Type
Drug
Intervention Name(s)
FST-100 Vehicle
Intervention Description
FST-100 Vehicle
Primary Outcome Measure Information:
Title
Adenoviral eradication and clinical resolution of the infection
Time Frame
6-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Ora, Inc.
City
Noida
ZIP/Postal Code
201301
Country
India
12. IPD Sharing Statement
Learn more about this trial
FST-100 in the Treatment of Acute Adenoviral Conjunctivitis
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