Evaluation of Comfort in Symptomatic Contact Lens Wearers | NCT04963543

Studies
Evaluation of Comfort in Symptomatic Contact Lens Wearers

NCT04963543

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 3, 2021Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Ocular Comfort

Interventions

FID123238

Countries

Canada

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

Nov 2021

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

Jul 22, 2021Actual

Primary Completion Date

Oct 29, 2021Actual

Completion Date

Oct 29, 2021Actual

First Submitted Date

Jul 6, 2021

First Submission Date that Met QC Criteria

Jul 6, 2021

First Posted Date

Jul 15, 2021Actual

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 2, 2021

Last Update Posted Date

Nov 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.

Detailed Description

The duration of individual participation is six days.

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

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FID123238	Experimental	FID123238 applied to the ocular surface, 1 application per day, for five consecutive days	Other: FID123238

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FID123238	Other	Lubricant applied to the ocular surface	FID123238

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comfort, collected for each eye	A visual analogue scale will be used	Up to Day 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Is able to understand and sign an approved information consent letter;
Habitually wears daily disposable soft contact lenses in both eyes;
Is able to achieve 20/40 or better monocular VA with habitual contact lenses;
Has a pair of spectacles for vision correction.
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

Routinely sleeps in habitual contact lenses;
Has any known active ocular disease and/or infection;
Is pregnant or lactating;
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

Name	Affiliation	Role
Clinical Trial Lead, Dry Eye	Alcon Research, LLC	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alcon Investigative Site 6189		Waterloo	Ontario	N2L 3G1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided