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

This study has been terminated.
(Internal business decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00901693
First received: May 8, 2009
Last updated: May 7, 2014
Last verified: May 2014

May 8, 2009
May 7, 2014
June 2009
July 2010   (final data collection date for primary outcome measure)
Sustained microbiological success at Day 5 or Day 7 [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]
Microbiological success at any visit [ Time Frame: Days 1,3,5,7,9,11 and 18 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00901693 on ClinicalTrials.gov Archive Site
Time to sustained microbiological success [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]
  • Time to microbiological success [ Time Frame: Days to microbiological success ] [ Designated as safety issue: No ]
  • Clinical cure at each visit [ Time Frame: Days 1,3,5,7,9,11 and 18 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Not Provided

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Adenoviral Conjunctivitis
  • Drug: AL-46383A Ophthalmic Solution
  • Drug: AL-46383A Ophthalmic Solution Vehicle
  • Experimental: AL-46383A
    AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days
    Intervention: 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
    Intervention: Drug: AL-46383A Ophthalmic Solution Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
452
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00901693
C-07-53
No
Alcon Research
Alcon Research
Not Provided
Study Director: Sally Scheib Alcon Research
Alcon Research
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP