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

NCT00901693 | Terminated Phase 2

• 1 other identifier: C-07-53
• Study Type: interventional
• Target: 452
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adenoviral Conjunctivitis

Keywords

pink eye; eye infection; conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Sustained microbiological success at Day 5 or Day 7

  Up to Day 18

Secondary Outcomes (1)

• Time to sustained microbiological success

  Up to Day 18

Study Arms (2)

AL-46383A

EXPERIMENTAL

AL-46383A Ophthalmic Solution, 1 drop in each eye, 8 times a day for 10 days

Drug: AL-46383A Ophthalmic Solution

Vehicle

PLACEBO COMPARATOR

AL-46383A Ophthalmic Solution Vehicle, 1 drop in each eye, 8 times a day, for 10 days

Drug: AL-46383A Ophthalmic Solution Vehicle

Interventions

AL-46383A Ophthalmic Solution DRUG

AL-46383A

AL-46383A Ophthalmic Solution Vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis; Eye Infections

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Infections

Study Officials

• Sally Scheib

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 14, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 22, 2014

Record last verified: 2014-05