FST-100 in the Treatment of Acute Viral Conjunctivitis
This study is not yet open for participant recruitment.
Verified August 2012 by Foresight Biotherapeutics
Sponsor:
Foresight Biotherapeutics
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01461954
First received: October 24, 2011
Last updated: August 21, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Viral Conjunctivitis |
Drug: FST-100 Drug: FST-100 Vehicle |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of FST-100 Ophthalmic Suspension in the Treatment of Acute Viral Conjunctivitis |
Resource links provided by NLM:
Further study details as provided by Foresight Biotherapeutics:
Primary Outcome Measures:
- Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FST-100 |
Drug: FST-100
FST-100
|
| Placebo Comparator: FST-100 Vehicle |
Drug: FST-100 Vehicle
FST-100 Vehicle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461954
Contacts
| Contact: Ora Inc. | 978-685-8900 |
Locations
| United States, Massachusetts | |
| Ora Clinical Site | Not yet recruiting |
| Please Contact Ora Call Center for Trial Locations, Massachusetts, United States | |
| Contact: Ora, Inc. 978-685-8900 | |
| Brazil | |
| Ora Clinical Site | Not yet recruiting |
| Please Contact Ora Call Center for Trial Locations, Brazil | |
| Contact: Ora, Inc. 978-685-8900 | |
Sponsors and Collaborators
Foresight Biotherapeutics
Investigators
| Study Director: | Aron Shapiro | ORA, Inc. |
More Information
No publications provided
| Responsible Party: | Foresight Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT01461954 History of Changes |
| Other Study ID Numbers: | FST100-AVC-005 |
| Study First Received: | October 24, 2011 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Food and Drug Administration Brazil: ANVISA |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Viral Conjunctival Diseases Eye Diseases |
Eye Infections, Viral Virus Diseases Eye Infections |
ClinicalTrials.gov processed this record on May 22, 2013