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RecruitingNCT06955403Updated Nov 26, 2025

Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Contact Lenses

An interventional study of Precision 7 contact lenses in Contact Lens Comfort, sponsored by Southern College of Optometry. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by Southern College of Optometry · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Contact Lens Comfort
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    PRECISION7

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

    Device: Precision 7 contact lenses

Interventions

  • DevicePrecision 7 contact lenses

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

05

What researchers measure

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.

    Time frame: 1 week

06

Study locations

1 of 1 sites recruiting
  • The Southern College of Optometry
    Memphis, Tennessee 38104, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06955403
Lead sponsor
Southern College of Optometry
Collaborators
Eminent Ophthalmic Services
Responsible party
Sponsor
First posted
May 2, 2025
Start date
Apr 15, 2025
Primary completion
Aug 31, 2025
Completion
Nov 30, 2025 (estimated)
Last update
Nov 26, 2025

Study contacts

Chris Lievens, OD
Contact
clievens@sco.edu
9014815699
Chris Lievens
principal investigator · The Southern College of Optometry

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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