CompletedInterventionalPhase 2Updated Oct 15, 2025
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis | NCT00901693 | Trialant
TerminatedInterventionalPhase 2Updated May 22, 2014
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
ClinicalTrials.gov ID
NCT00901693
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 2
Enrollment
452Actual
Last Update Posted
May 22, 2014Estimated
Start Date
Jun 2009
Primary Completion Date
Jul 2010Actual
Completion Date
Jul 2010Actual
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.
Adenoviral Conjunctivitis
AL-46383A Ophthalmic Solution
AL-46383A Ophthalmic Solution Vehicle
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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.
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.