Evaluation of an Investigational Multi-Purpose Disinfecti... | NCT00382603

Studies
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

NCT00382603

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Aug 16, 2012Estimated

Enrollment

362

Phase

Not Applicable

Conditions

Contact Lens Care

Interventions

OptiFree Multi-Purpose Disinfecting Solution

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

Sep 2006

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

Aug 2004

Primary Completion Date

Feb 2005Actual

Completion Date

Feb 2005Actual

First Submitted Date

Sep 28, 2006

First Submission Date that Met QC Criteria

Sep 28, 2006

First Posted Date

Sep 29, 2006Estimated

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 15, 2012

Last Update Posted Date

Aug 16, 2012Estimated

Description Module

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.

Detailed Description

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

362

Name	Type	Description	Arm Group Labels	Other Names
OptiFree Multi-Purpose Disinfecting Solution	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events

Secondary Outcomes

Measure	Description	Time Frame
Corneal Fluorescein Staining (Type and Area)
Lens Surface Evaluation (Lens Deposit and Lens Wettability)
Lens Replacement Incidence and Causality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic for contact lens related discomfort at the end of the lens wearing day.
Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
Successful lens wear for at least 4 hours per day.
Vision correctable to 20/30.
Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
No corneal surgery within the past 12 months.
No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
No over-the-counter or prescription ocular medication.
No enrollment in another clinical study within 30 days prior to enrollment.

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

Name	Affiliation	Role
Leslie Napier	Alcon Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Highlands Ranch		Highlands Ranch	Colorado	80126	United States