Precision 7 Contact Lenses for Contact Lens Comfort

Overseen By Chris Lievens, OD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Southern College of Optometry

Must not be taking: Isotretinoin, Ocular medications

Disqualifiers: Presbyopia, Dry eye, Ocular allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using isotretinoin-derivatives or ocular medications.

What data supports the effectiveness of the treatment Precision 7 contact lenses for contact lens comfort?

Research suggests that the material, design, and fitting of contact lenses can significantly impact comfort, which is a key focus of the Precision 7 contact lenses. Studies on similar 'comfort-enhanced' lenses and the relationship between vision and comfort indicate that improvements in these areas can lead to better comfort for wearers. ^{1 2 3 4 5}

What safety data exists for Precision 7 contact lenses?

The safety of contact lenses, including those similar to Precision 7, has been studied in terms of comfort and adverse events (unwanted effects). Research shows that different materials and designs can affect comfort and the likelihood of adverse events, but specific safety data for Precision 7 is not detailed in the available studies. ^{5 6 7 8 9}

How do Precision 7 contact lenses differ from other contact lens treatments for comfort?

Precision 7 contact lenses are designed to enhance comfort, potentially offering a unique material or design that improves wearability compared to other types of contact lenses, such as rigid gas permeable or hydrogel lenses. While specific details about Precision 7 are not provided, the focus on comfort suggests they may incorporate advanced materials or designs to reduce discomfort during wear. ^{1 2 3 5 10}

What is the purpose of this trial?

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

Research Team

Chris Lievens

Principal Investigator

The Southern College of Optometry

Eligibility Criteria

This trial is for adults aged 18-40 who have worn Acuvue Oasys contact lenses for at least 3 months, have astigmatism between 0.75D to 2.50D in each eye, and are satisfied with their current lenses. Participants must be able to wear Precision 7 contact lenses daily for over 13 hours without overnight use and have a recent glasses prescription.

Inclusion Criteria

Astigmatism ranging from 0.75 D to 2.50 D in each eye

Participants must have worn AOA CLs for at least 3 months in the past year and currently wearing these CLs

Participants must be able to wear P7A CLs (astigmatism ≥0.75D OD/OS)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are refitted from Acuvue Oasys for Astigmatism contact lenses to PRECISION7 for Astigmatism contact lenses

1 week

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction, comfort, and vision quality after refitting

1 week

Treatment Details

Interventions

• Precision 7 contact lenses

Trial Overview The study aims to see if people happy with their Acuvue Oasys contacts can switch successfully to Precision 7 contact lenses designed for astigmatism. It involves regular wearing of the new P7A lenses during waking hours over a set period.

Participant Groups

Group I: PRECISION7 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Southern College of Optometry

Lead Sponsor

Trials

8

Recruited

390+

Eminent Ophthalmic Services

Collaborator

Findings from Research

In a study of 74 children aged 8 to 12, MiSight contact lenses were found to be a safe option for myopia correction, with no serious or significant adverse events reported over a 2-year period.

While there were some nonsignificant adverse events and a few discontinuations in the MiSight group, the overall safety profile was comparable to that of distance single-vision spectacles, indicating that both options are effective for managing myopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. Ruiz-Pomeda, A., Pérez-Sánchez, B., Prieto-Garrido, FL., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Objective clinical performance of 'comfort-enhanced' daily disposable soft contact lenses. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Randomised controlled study comparing comfort-related outcomes between two rigid gas permeable (RGP) lenses with different sessile drop contact angles. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

The Relationship Between Vision and Comfort in Contact Lens Wear. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Real-Time Ocular Comfort Reporting in Monthly Replacement Contact Lens Wearers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Contact Lens Material, Design, and Fitting on Discomfort. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Combined effect of comfort and adverse events on contact lens performance. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse events and discontinuations during 18 months of silicone hydrogel contact lens wear. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Contact lens-related adverse events and the silicone hydrogel lenses and daily wear care system used. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Ocular surface comfort during the day assessed by instant reporting in different types of contact and non-contact lens wearers. [2017]