Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Co... | NCT06955403

Studies
Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Contact Lenses

NCT06955403

Sponsor

Southern College of Optometry

Status

Recruiting

Last Update Posted

Nov 26, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Contact Lens Comfort

Interventions

Precision 7 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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2025Actual

Primary Completion Date

Aug 31, 2025Actual

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Apr 24, 2025

First Submission Date that Met QC Criteria

Apr 24, 2025

First Posted Date

May 2, 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

Nov 25, 2025

Last Update Posted Date

Nov 26, 2025Actual

Name	Class
Eminent Ophthalmic Services	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Determine the likelihood of successfully refitting a satisfied AOA CL wearers into P7A CLs

Detailed Description

PRECISION7m for Astigmatism is a 1-week, silicone hydrogel (serafilcon A), daily wear, contact lens (CL) with extended wear approval made of a novel material that incorporates the Activ-Flo System. The Activ-Flo System has a moisturizing agent within the CL matrix, which allows for continual release of the moisturizing agents while also providing up to 16 hours of comfortable wear and precise vision for the life of the CL. While initial P7A data are promising, the literature currently lacks a targeted study aimed at determining how patients perform in P7A after transitioning out of other commonly prescribed silicone hydrogel CLs. This transition could be particularly important for patients who have astigmatism given that they tend to struggle with CLs more than spherical CL wearers.1 Thus, the purpose of this study is to determine the success rate of refitting current, satisfied ACUVUE OASYS for Astigmatism CL wearers into P7A. Understanding how a P7A CL wearer reacts to transitioning into P7A from AOA will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting successful AOA patients into the newer P7A technology, which could help grow the P7A CL market by not limiting P7A refits to problem-solving events.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRECISION7	Experimental	Determine the likelihood of successfully refitting a satisfied Acuvue Oaysis Contact Lens wearers into P7A CLs.	Device: Precision 7 contact lenses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Precision 7 contact lenses	Device	Acuvue Oaysis contact lens wearers have will be refit into precision 7 contact lenses.	PRECISION7

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Likert questionnaire	1. Likelihood of continuing to wear P7A, 2. Overall satisfaction while wearing P7A, 3. Overall vision while wearing P7A, 4. End of day comfort while wearing P7A, 5. End of day vision while wearing P7A, 6. Overall comfort while wearing P7A, 7. Ability to play sports and perform fitness actives while wearing P7A, 8. Ability to use digital devices while wearing P7A (questions attached). 9. Would recommend the study CLs to a friend.	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

• Inclusion Criteria: Adults, 18- to 40-year-old, AOA CL wearers with best-corrected 20/20 visual acuity or better.

Participants will be required to have worn AOA 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 (AOA CLs) and to indicate that they are satisfied with AOA CLs (Yes/No).
Participants will be required to be able to wear P7A CLs (astigmatism ≥0.75D OD/OS).
Astigmatism ranging from 0.75 D to 2.50 D in each eye
Participants will be required to wear the study CLs for ≥13 hours with no overnight wear
Participants will be willing to wear the CL every day of the week, except during the washout period
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 P7A in the past
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 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

Name	Role	Phone	Extension	Email
Chris Lievens, OD	Contact	9014815699		clievens@sco.edu

Name	Affiliation	Role
Chris Lievens	The Southern College of Optometry	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Southern College of Optometry	Recruiting	Memphis	Tennessee	38104	United States

Intervention Model Description

This will be a prospective study to understand if satisfied AOA CL wearers can be successfully refit into P7A CLs. The Primary Endpoint will be analyzed as the proportion of participants who have CLDEQ-8 scores <12 at the end of the study; thus, no comparison will occur with the Primary Endpoint and no formal sample size calculation can be performed