How Does DT1 Sphere Perform in Current and Successful Acu... | NCT06847230

Studies
How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?

NCT06847230

Sponsor

Southern College of Optometry

Status

Completed

Last Update Posted

Aug 12, 2025Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Contact Lens Comfort and Successful Refitting

Interventions

Dailies total 1 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 2025

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 15, 2024Actual

Primary Completion Date

Nov 1, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Feb 21, 2025

First Submission Date that Met QC Criteria

Feb 21, 2025

First Posted Date

Feb 26, 2025Actual

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 7, 2025

Last Update Posted Date

Aug 12, 2025Actual

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this prospective study is to to understand if satisfied MAX Contact lens (CL)wearers can be successfully refit into Dailies total 1 (DT1) CL in healthy MAX CL wearers between the ages of 18-40. The main question is to determine the number of participants who can successfully be re-fit into DT1 CL, by utilizing a cldeq-8 questionnaire as well as an investigator developed questionnaire to gauge comfort and satisfaction.

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dailies total 1 contact lenses	Experimental	Acuvue max wearers will be refit into dailies total 1	Device: Dailies total 1 contact lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dailies total 1 contact lenses	Device	successful refit into dt1 will be determined	Dailies total 1 contact lenses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Likelihood of continuing to wear DT1	A Likert questionnaire will be used to determine patient-reported outcomes -50 being uncomfortable and 50 being extremely comfortbale	3 weeks
Overall satisfaction while wearing DT1	A Likert questionnaire will be used to determine patient-reported outcomes. With answers that are positive such as strongly agree to product satisfaction are better.	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:
Adults, 18- to 40-year-old, Oasys MAX 1-day CL wearers with best-corrected 20/20 visual acuity or better.
Participants will be required to have worn Oasys MAX 1-day CLs for at least 3 months in the past year and currently wearing these CLs.
All participants will be required to have a CLDEQ-8 score <12 while wearing their habitual CLs (Oasys MAX 1-days) and to indicate that they are satisfied with Oasys MAX 1-day CLs (Yes/No).
Participants will be required to be able to wear DT1 Sphere CLs (astigmatism < 0.75D OD/OS).
Participants will be required to wear the study CLs for ≥12 hours with no overnight wear
Participants will be required to use digital devices at least 8 hours/day.
Participants will be required to provide a glasses prescription that is less than 3 years old.
Exclusion Criteria:
Have presbyopia and/or need a reading add as determined during their initial manifest refraction.
Have worn DT1 in the past for more than 1 week.
Are past rigid CL wearers.
Have a history of being diagnosed with dry eye or ocular allergies.
Have known systemic health conditions that are thought to alter tear film physiology.
Have corrected acuity 1 line or more worse vision recorded at Visit 2 (compared to the Visit 1 findings) with their optimized Oasys MAX 1-day lenses.
Have a history of viral eye disease.
Have a history of ocular surgery.
Have a history of severe ocular trauma.
Have a history of corneal dystrophies or degenerations.
Have active ocular infection or inflammation.
Are currently using isotretinoin-derivatives or ocular medications.
Are pregnant or breast feeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided