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

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.