Clinical Performance of a Daily Disposable Toric Silicone... | NCT04464044

Studies
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

NCT04464044

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Aug 19, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Astigmatism

Interventions

verofilcon A toric 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

Aug 2020

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 20, 2020Actual

Primary Completion Date

Aug 6, 2020Actual

Completion Date

Aug 6, 2020Actual

First Submitted Date

Jul 7, 2020

First Submission Date that Met QC Criteria

Jul 7, 2020

First Posted Date

Jul 9, 2020Actual

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, 2020

Last Update Posted Date

Aug 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Detailed Description

This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DDT2 Toric	Experimental	Verofilcon A toric contact lenses worn in both eyes	Device: verofilcon A toric contact lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
verofilcon A toric contact lenses	Device	Daily disposable toric soft contact lenses	DDT2 Toric

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion	Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.	Day 1, 10 minutes after lens insertion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to understand and sign an informed consent form;
Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
Willing to NOT use rewetting/lubricating drops at any time during the study;
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
History of eye surgery within the previous 12 months, as specified in the protocol;
Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Other protocol-specified 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, Vision Care	Alcon Research, LLC	Study Director

Locations

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

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

Condition Browse Module

MeSH Terms

ID	Term
D001251	Astigmatism

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided