FST-100 in the Treatment of Acute Viral Conjunctivitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01461954 |
Recruitment Status :
Completed
First Posted : October 28, 2011
Last Update Posted : September 30, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Viral Conjunctivitis | Drug: FST-100 Drug: FST-100 Vehicle | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: FST-100 |
Drug: FST-100
FST-100 |
Placebo Comparator: FST-100 Vehicle |
Drug: FST-100 Vehicle
FST-100 Vehicle |
- Clinical resolution of acute viral conjunctivitis [ Time Frame: 6-7 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461954
United States, Massachusetts | |
Ora Clinical Site | |
Please Contact Ora Call Center for Trial Locations, Massachusetts, United States | |
Brazil | |
Ora Clinical Site | |
Please Contact Ora Call Center for Trial Locations, Brazil |
Study Director: | Aron Shapiro | ORA, Inc. |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01461954 |
Other Study ID Numbers: |
FST100-AVC-005 |
First Posted: | October 28, 2011 Key Record Dates |
Last Update Posted: | September 30, 2015 |
Last Verified: | March 2015 |
Conjunctivitis, Viral Conjunctivitis Conjunctival Diseases Eye Diseases |
Eye Infections, Viral Virus Diseases Eye Infections |