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

NCT ID: NCT00901693

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-07-31

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.

Conditions

Adenoviral Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AL-46383A

AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days

Group Type: EXPERIMENTAL

AL-46383A Ophthalmic Solution

Intervention Type: DRUG

Vehicle

AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days

Group Type: PLACEBO_COMPARATOR

AL-46383A Ophthalmic Solution Vehicle

Intervention Type: DRUG

Interventions

AL-46383A Ophthalmic Solution

Intervention Type: DRUG

AL-46383A Ophthalmic Solution Vehicle

Intervention Type: DRUG

Eligibility 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.

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally Scheib

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-07-53

Identifier Type: -

Identifier Source: org_study_id