An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Alcon

Status and phase

Terminated

Phase 2

Conditions

Adenoviral Conjunctivitis

Treatments

Drug: AL-46383A Ophthalmic Solution

Drug: AL-46383A Ophthalmic Solution Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

C-07-53

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.

Enrollment

452 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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 exclusion criteria may apply.