Adenoviral Conjunctivitis
Conditions
Keywords
pink eye, eye infection, conjunctivitis
Brief summary
The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.
Interventions
DRUGAL-46383A Ophthalmic Solution
DRUGAL-46383A Ophthalmic Solution Vehicle
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist. * Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye. * Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC). * Must agree to comply with the visit schedule and other requirements of the study. * Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Sub-epithelial infiltrates at the Day 1 visit in either eye. * Corneal opacity or any corneal abnormality at the Day 1 visit in either eye. * Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction. * Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit. * Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit. * Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation. * History of active uveitis or iritis in either eye. * History of corneal transplant in either eye. * Presence of nasolacrimal duct obstruction at Day 1. * Use of specified prohibited medications. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained microbiological success at Day 5 or Day 7 | Up to Day 18 |
Secondary
| Measure | Time frame |
|---|---|
| Time to sustained microbiological success | Up to Day 18 |
Outcome results
None listed