Acute Adenoviral Conjunctivitis
Conditions
Brief summary
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.
Interventions
DRUGFST-100 Ophthalmic Suspension
FST-100 (PVP-I 0.4% and dexamethasone 0.1%). A regimen of 2 drops 4 times a day while awake for 5 days.
DRUGPlacebo
A regimen of 2 drops 4 times a day while awake for 5 days.
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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: 1. conjunctival injection/inflammation, and 2. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure is defined as a reduction of conjunctival injection and discharge scaled scored each to 0/3. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in viral titer by qPCR. Eradication of infectious virus determined by CC-IFA. | 1 year |
Countries
United States
Outcome results
None listed