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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00901693
First received: May 8, 2009
Last updated: March 9, 2011
Last verified: March 2011
  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
Conjunctivitis Due to Adenovirus
Drug: AL-46383A Ophthalmic Solution
Drug: AL-46383A 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:
  • Microbiological success at any visit [ Time Frame: Days 1,3,5,7,9,11 and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: June 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AL-46383A Ophthalmic Solution
topical eye drop dosed 8 times per day for 10 days
Placebo Comparator: 2 Drug: AL-46383A Vehicle
topical eye drop dosed 8 times per day for 10 days

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
  3. Be 6 years or older and of any race and either sex.
  4. Must be able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
  5. Must agree to comply with the visit schedule and other requirements of the study.
  6. 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.

Exclusion Criteria:

  1. Presence of sub-epithelial infiltrates at the Day 1 visit in either eye.
  2. Presence of corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
  3. Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
  4. 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.
  5. 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.
  6. Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
  7. Patients with a history of active uveitis or iritis in either eye.
  8. Patients with a history of corneal transplant in either eye.
  9. Presence of nasolacrimal duct obstruction at Day 1.
  10. Use of specified prohibited medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901693

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Sally Scheib / Clinical Trial Manager, Alcon Research
ClinicalTrials.gov Identifier: NCT00901693     History of Changes
Other Study ID Numbers: C-07-53
Study First Received: May 8, 2009
Last Updated: March 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
pink eye
eye infection
conjunctivitis

Additional relevant MeSH terms:
Adenoviridae Infections
Conjunctivitis
Conjunctivitis, Inclusion
DNA Virus Infections
Virus Diseases
Conjunctival Diseases
Eye Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection

ClinicalTrials.gov processed this record on April 16, 2014