An Evaluation of the Efficacy and Safety of AL-46383A Oph... | NCT00901693

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

NCT00901693

Sponsor

Alcon Research

Status

Terminated

Last Update Posted

May 22, 2014Estimated

Enrollment

452Actual

Phase

Phase 2

Conditions

Adenoviral Conjunctivitis

Interventions

AL-46383A Ophthalmic Solution
AL-46383A Ophthalmic Solution Vehicle

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Internal business decision

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

May 8, 2009

First Submission Date that Met QC Criteria

May 13, 2009

First Posted Date

May 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Apr 17, 2014

Certification/Extension First Submitted that Passed QC Review

May 7, 2014

Certification/Extension First Posted Date

May 22, 2014Estimated

Last Update Submitted Date

May 7, 2014

Last Update Posted Date

May 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

452Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
AL-46383A Ophthalmic Solution	Drug		AL-46383A
AL-46383A Ophthalmic Solution Vehicle

Measure	Description	Time Frame
Sustained microbiological success at Day 5 or Day 7		Up to Day 18

Measure	Description	Time Frame
Time to sustained microbiological success		Up to Day 18

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003229	Conjunctival Diseases
D005128	Eye Diseases
D007239	Infections

ID	Term
D003231	Conjunctivitis
D015817	Eye Infections