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
  Purpose

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


Condition Intervention Phase
Adenoviral Conjunctivitis
Drug: AL-46383A Ophthalmic Solution
Drug: AL-46383A Ophthalmic Solution Vehicle
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Sustained microbiological success at Day 5 or Day 7 [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to sustained microbiological success [ Time Frame: Up to Day 18 ] [ Designated as safety issue: No ]

Enrollment: 452
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901693

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sally Scheib Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00901693     History of Changes
Other Study ID Numbers: C-07-53
Study First Received: May 8, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
pink eye
eye infection
conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014