Wettability of Contact Lenses With a Multi-Purpose Solution | NCT00713076

Studies
Wettability of Contact Lenses With a Multi-Purpose Solution

NCT00713076

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Aug 20, 2014Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Vision

Interventions

Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182

Countries

United States

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

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Not provided

First Submitted Date

Jun 18, 2008

First Submission Date that Met QC Criteria

Jul 10, 2008

First Posted Date

Jul 11, 2008Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2014

Last Update Posted Date

Aug 20, 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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Polyquaternium-preserved Multi-purpose solution	Other: Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polyquaternium-preserved Multi-purpose Lens Cleaning Solution 109182	Other	Lens Cleaning Solution Formulation Identification Number 109182	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lens Wettability - ex-vivo wetting angle		From baseline

Secondary Outcomes

Measure	Description	Time Frame
Slit-lamp findings Corrected visual acuity (snellen) Adverse events		From baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with normal eyes who have successfully worn contact lenses on a daily basis for at least two weeks prior to the study.
Must be wearing lenses a minimum of eight hours a day
Vision must be correctable to 20/30 (snellen) or better in each eye at a distance with soft contact lenses
Use no topical ocular OTC or prescribed ocular medication

Exclusion Criteria:

Subjects with current lid or conjunctival infections, abnormalities, inflammation, abnormal corneal opacities, significant lenticular inclusions, iritis, ocular disease or condition, corneal surgery, cataract surgery, intraocular lens implants, or glaucoma filtering surgery.
Subjects using systemic medications, upper respiratory infections or colds, history of seasonal allergies with significant ocular side effects

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Contact Alcon Call Center for Study Locations		Fort Worth	Texas	76134	United States