FST-100 in the Treatment of Acute Adenoviral Conjunctivitis
This study is currently recruiting participants.
Verified December 2012 by Foresight Biotherapeutics
Sponsor:
Foresight Biotherapeutics
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01470664
First received: November 9, 2011
Last updated: December 21, 2012
Last verified: December 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 adenoviral conjunctivitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Adenoviral Conjunctivitis |
Drug: FST-100 Drug: FST-100 (Component #1) Drug: FST-100 Vehicle |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Foresight Biotherapeutics:
Primary Outcome Measures:
- Adenoviral eradication and clinical resolution of the infection [ Time Frame: 6-7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 176 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FST-100 |
Drug: FST-100
FST-100
|
| Experimental: FST-100 (Component #1) |
Drug: FST-100 (Component #1)
FST-100 (Component #1)
|
| 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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470664
Contacts
| Contact: Ora, Inc. | 978-685-8900 |
Locations
| United States, Massachusetts | |
| Ora, Inc. | Recruiting |
| Andover, Massachusetts, United States, 01810 | |
| Contact: Please Contact Ora for Trial Locations 978-685-8900 | |
| India | |
| Ora, Inc. | Recruiting |
| Noida, India, 201301 | |
| Contact: Please Contact Ora for Trial Locations 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: | NCT01470664 History of Changes |
| Other Study ID Numbers: | FST100-AVC-004 |
| Study First Received: | November 9, 2011 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration India: Drugs Controller General of India |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Inclusion Conjunctival Diseases Eye Diseases Conjunctivitis, Bacterial Eye Infections, Bacterial |
Bacterial Infections Chlamydia Infections Chlamydiaceae Infections Gram-Negative Bacterial Infections Eye Infections Infection |
ClinicalTrials.gov processed this record on May 23, 2013