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

Adenoviral Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00901693
• Other study ID #: C-07-53
• Status: Terminated
• Phase: Phase 2
• First received: May 8, 2009
• Last updated: May 7, 2014
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 452
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoviral Conjunctivitis
• Conjunctivitis

Intervention

Drug:
• AL-46383A Ophthalmic Solution

• AL-46383A Ophthalmic Solution Vehicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained microbiological success at Day 5 or Day 7		Up to Day 18	No
Secondary	Time to sustained microbiological success		Up to Day 18	No