FST-100 Ophthalmic Suspension in Acute Adenoviral Conjunctivitis
This study has been terminated.
Sponsor:
Foresight Biotherapeutics
Information provided by (Responsible Party):
Foresight Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00941486
First received: July 15, 2009
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
The objective of this study is to evaluate the efficacy of FST-100 (0.1% dexamethasone) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Adenoviral Conjunctivitis |
Drug: FST-100 (0.1% dexamethasone) Ophthalmic Suspension Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Foresight Biotherapeutics:
Primary Outcome Measures:
- Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FST-100 (0.1% dexamethasone) Ophthalmic Suspension |
Drug: FST-100 (0.1% dexamethasone) Ophthalmic Suspension
A regimen of 2 drops 4 times a day while awake for 5 days.
|
| Placebo Comparator: Vehicle |
Drug: Placebo
A regimen of 2 drops 4 times a day while awake for 5 days.
|
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge.
- Clinical suspicion of adenoviral etiology.
- At least three (3) years of age.
- Subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent.
Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis:
- conjunctival injection/inflammation, and
- conjunctival discharge/exudates.
Exclusion Criteria:
- Conjunctivitis longer than 7 days after initial ocular symptoms.
- Corneal ulcer, endophthalmitis, or any other confounding infection of the eye.
- Patients taking ocular anti-inflammatory medications on a chronic basis.
- Active herpes ocular infection.
- Known or suspected pregnancy.
- Known allergy to PVP-I.
- Known allergy to dexamethasone.
- Patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders".
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941486
Locations
| United States, California | |
| Wolstan and Goldberg Eye Associates | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| Colorado Eye Associates | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Connecticut | |
| Eye Center | |
| Hamden, Connecticut, United States, 06518 | |
| United States, Florida | |
| The Center for Excellence in Eye | |
| Miami, Florida, United States, 33176 | |
| Ocean Ophthalmology | |
| North Miami Beach, Florida, United States, 33179 | |
| United States, Illinois | |
| The Midwest Center for Sight | |
| Des Plaines, Illinois, United States, 60016 | |
| Hoffman Estates, Illinois, United States, 60169 | |
| United States, Missouri | |
| Silverstein Eye Centers | |
| Kansas City, Missouri, United States, 64133 | |
| St. Johns Clinic | |
| Springfield, Missouri, United States, 65804 | |
| United States, New York | |
| Ophthalmic Consultants PC The New York Eye and Ear Infirmary | |
| New York, New York, United States, 10003 | |
| Wantagh, New York, United States, 11793 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Columbus Ophthalmology Associates | |
| Columbus, Ohio, United States, 43213 | |
Sponsors and Collaborators
Foresight Biotherapeutics
More Information
No publications provided
| Responsible Party: | Foresight Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00941486 History of Changes |
| Other Study ID Numbers: | FST100-AVC-02 |
| Study First Received: | July 15, 2009 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate |
BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013