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?

Overview

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.

Interventions

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

Primary outcome measures

• Likert questionnaire [Time frame: 1 week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• The Southern College of Optometry — Memphis

Identifiers

NCT: NCT06955403 · P7

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗