Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Contact Lenses

NCT06955403 | Recruiting FDA Device

• 1 other identifier: P7
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contact Lens Comfort

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PRECISION7

EXPERIMENTAL

Determine the likelihood of successfully refitting a satisfied Acuvue Oaysis Contact Lens wearers into P7A CLs.

Device: Precision 7 contact lenses

Interventions

Precision 7 contact lenses DEVICE

Acuvue Oaysis contact lens wearers have will be refit into precision 7 contact lenses.

PRECISION7

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Southern College of Optometry: lead
• Eminent Ophthalmic Services: collaborator

Study Sites (1)

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

RECRUITING

Study Officials

• Chris Lievens

  The Southern College of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Lievens, OD

CONTACT

9014815699; clievens@sco.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: April 15, 2025
• Primary Completion: August 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)