Assessing Patient Comfort With Two Different Multi-Purpos... | NCT01847105

Studies
Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

NCT01847105

Sponsor

Hom, Milton M., OD, FAAO

Status

Unknown status

Last Update Posted

May 29, 2013Estimated

Enrollment

54Estimated

Phase

Not Applicable

Conditions

Contact Lens Solution Toxicity

Interventions

RevitaLens
OptiFree PureMoist

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

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

May 2014Estimated

First Submitted Date

Apr 24, 2013

First Submission Date that Met QC Criteria

May 1, 2013

First Posted Date

May 6, 2013Estimated

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

May 25, 2013

Last Update Posted Date

May 29, 2013Estimated

Name	Class
Abbott Medical Optics	INDUSTRY

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

Description Module

Brief Summary

Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).

Detailed Description

According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.

The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.

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

54Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RevitaLens	Experimental	AMO's RevitaLens contact lens solution	Other: RevitaLens Other: OptiFree PureMoist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RevitaLens	Other	Multi-purpose disinfecting solution	RevitaLens	AMO's RevitaLens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported comfort scores with contact lens care systems	Comfort measured by questionnaires covering positive and negative attributes of contact lens wear	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between the ages of 18 and over inclusive.
Males or females
Patient is in generally good & stable overall health.
Patient likely to comply with study guidelines & study visits.
Informed consent signed.
Are willing/able to return for all required study visits.
Are willing/able to follow instructions from the study investigator and his/her staff.
Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study.
Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

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
Milton M Hom, OD FAAO		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milton M. Hom, OD, FAAO		Azusa	California	91702	United States
Kirk L. Smick, OD, FAAO.