Clinical trial NCT06955403: Acuvue Oaysis Contact Lens Wearers Being Refit Into P7 Contact Lenses
Official title: How Does PRECISION7® for Astigmatism Perform in Current and Successful Acuvue® Oasys for Astigmatism Wearers?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contact Lens Comfort
Lead sponsor: Southern College of Optometry
Sponsor class: OTHER
Collaborators: name: Eminent Ophthalmic Services
First posted: 2025-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adults, 18- to 40-year-old, AOA CL wearers with best-corrected 20/20 visual acuity or better.
2. Participants will be required to have worn AOA CLs for at least 3 months in the past year and currently wearing these CLs.
3. 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).
4. Participants will be required to be able to wear P7A CLs (astigmatism ≥0.75D OD/OS).
5. Astigmatism ranging from 0.75 D to 2.50 D in each eye
6. Participants will be required to wear the study CLs for ≥13 hours with no overnight wear
7. Participants will be willing to wear the CL every day of the week, except during the washout period
8. Participants will be required to provide a glasses prescription that is less than 3 years old

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Exclusion Criteria:

* 1. Have presbyopia and/or need a reading add as determined during their initial manifest refraction 2. Have worn P7A in the past 3. Are past rigid CL wearers 4. Have a history of being diagnosed with dry eye or ocular allergies 5. Have known systemic health conditions that are thought to alter tear film physiology 6. Have a history of viral eye disease 7. Have a history of ocular surgery 8. Have a history of severe ocular trauma 9. Have a history of corneal dystrophies or degenerations 10. Have active ocular infection or inflammation 11. Are currently using isotretinoin-derivatives or ocular medications 12. Are pregnant or breast feeding

Primary outcomes:
measure: Likert questionnaire
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: The Southern College of Optometry
state: Tennessee
Study officials:
affiliation: The Southern College of Optometry
name: Chris Lievens
role: PRINCIPAL_INVESTIGATOR
References: