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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901693
Recruitment Status : Terminated (Internal business decision)
First Posted : May 14, 2009
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Adenoviral Conjunctivitis Drug: AL-46383A Ophthalmic Solution Drug: AL-46383A Ophthalmic Solution Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Pinkeye
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Sustained microbiological success at Day 5 or Day 7 [ Time Frame: Up to Day 18 ]

Secondary Outcome Measures :
  1. Time to sustained microbiological success [ Time Frame: Up to Day 18 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901693

Sponsors and Collaborators
Alcon Research
Study Director: Sally Scheib Alcon Research

Responsible Party: Alcon Research Identifier: NCT00901693     History of Changes
Other Study ID Numbers: C-07-53
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Alcon Research:
pink eye
eye infection

Additional relevant MeSH terms:
Conjunctivitis, Inclusion
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Pharmaceutical Solutions
Ophthalmic Solutions