Clinical Evaluation of the Causes of Contact Lens Related... | NCT00995189

Studies
Clinical Evaluation of the Causes of Contact Lens Related Dry Eye

NCT00995189

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 17, 2016Estimated

Enrollment

159Actual

Phase

Not Applicable

Conditions

Contact Lens Related Dry Eye

Interventions

Opti-Free RepleniSH
ReNu MultiPlus
Contact lenses

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

Mar 2012

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 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 14, 2009

First Posted Date

Oct 15, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

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

The purpose of this study was to clinically evaluate the potential causes of contact lens-related dry eye.

Detailed Description

Daily wear soft contact lens wearers reporting significant contact lens-related dryness symptoms were enrolled. Late day dryness with contact lenses, intensity grade 3-5, frequency "sometimes / frequently / constantly" as evaluated by a questionnaire was considered significant.

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

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OFR	Experimental	Opti-Free RepleniSH contact lens care solution used for 30 days	Device: Opti-Free RepleniSH Device: Contact lenses
RNM	Active Comparator	ReNu MultiPlus contact lens care solution used for 30 days	Device: ReNu MultiPlus Device: Contact lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opti-Free RepleniSH	Device	Contact lens care solution containing polyquaternium-1 (PQT)	OFR

Measure	Description	Time Frame
Subjective Dryness		2 weeks, one month

Measure	Description	Time Frame
corneal staining		2 weeks, one month
conjunctival staining		two weeks, one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Reports late-day dryness symptoms with contact lens wear on questionnaire.
Wears FDA Group 2 hydrogel, FDA Group 4 hydrogel, or silicone hydrogel lenses.
Consistently uses either polyhexamethylene biguanide (PHMB) or polyquaternium-1 (PQT) contact lens care products (i.e. >6 months including 1 month immediately before enrollment).
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Wears daily disposable contact lenses.
Has significant symptoms related to lens fit or lens deposits.
Requires concurrent ocular medication (rewetting drops allowed).
Has used Restasis® in the last 3 months.
Wears punctal plugs fitted in the last 30 days.
Has any current systemic or ocular abnormality, infection or disease.
Uses any current systemic medication likely to affect tear film, e.g. antihistamines, betaadrenergic blockers, steroids.
Has a history of refractive surgery.
Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

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 Trial Locations		Fort Worth	Texas	76134	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27391535	Result	Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies