Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the efficacy of FST-100 (PVP-I 0.4% and dexamethasone 0.1%) Ophthalmic Suspension in the treatment of suspected acute adenoviral conjunctivitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FST-100 Ophthalmic Suspension | Experimental | FST-100 (PVP-I 0.4% and dexamethasone 0.1%) |
|
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FST-100 Ophthalmic Suspension | Drug | FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA. | 1 year |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolstan and Goldberg Eye Associates | Torrance | California | 90505 | United States | ||
| Colorado Eye Associates |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | A regimen of 2 drops 4 times a day while awake for 5 days. |
|
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Eye Center | Hamden | Connecticut | 06518 | United States |
| The Center for Excellence in Eye | Miami | Florida | 33176 | United States |
| Ocean Ophthalmology | North Miami Beach | Florida | 33179 | United States |
| The Midwest Center for Sight | Des Plaines | Illinois | 60016 | United States |
| Hoffman Estates | Illinois | 60169 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| St. Johns Clinic | Springfield | Missouri | 65804 | United States |
| Ophthalmic Consultants PC The New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Wantagh | New York | 11793 | United States |
| Charlotte | North Carolina | 28204 | United States |
| Columbus Ophthalmology Associates | Columbus | Ohio | 43213 | United States |