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

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

Study Overview

• Status: Terminated
• Conditions: Adenoviral Conjunctivitis
• Intervention / Treatment: Drug: AL-46383A Ophthalmic Solution; Drug: AL-46383A Ophthalmic Solution Vehicle

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AL-46383A; AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days	Drug: AL-46383A Ophthalmic Solution
Placebo Comparator: Vehicle; AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days	Drug: AL-46383A Ophthalmic Solution Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sustained microbiological success at Day 5 or Day 7	Up to Day 18

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to sustained microbiological success	Up to Day 18

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sally Scheib, Alcon Research

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 13, 2009
• First Posted (Estimate): May 14, 2009

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: pink eye; conjunctivitis; eye infection
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Conjunctivitis; Conjunctivitis, Inclusion; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: C-07-53