Recruiting

Total30 MFT

Sponsor:

Southern College of Optometry

Code:

NCT07586982

Conditions

Contact Lenses

Presbyopia

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Total 30 multi foric contact lenses

Study Details

Brief summary:

The goal of this clinical trial is to \[primary purpose: is to determine if Total30 Multi focal toric conntact lensesare comfortable and the willigness for those who have previously worn reusable toric contact lenses are willing to stay in Total30 MFT after 1 month of wear during the duration of the study. Healthy previous reusable toric contact lens weareres will be refit into total30 MFT contact lenses and will be asked to gauge their comfort while wearing the lenses. Healthy adult participants who are presybyopic between the ages of 18-40 can participant, sex and gender are not disqualifiers unless the participant is pregnant or breast feeding. The main question\[s\] it aims to answer \[is/are\]

\[primary hypothesis or outcome measure 1Proportions of toric CL wearers who have positive visual acuity scores in comfort and vision after one month of wear.

\[primary hypothesis or outcome measure 2\]? Contact lens dry eye-8 scores will be less than 12 indicating high levels of comfort after one month of wear.

Conditions

Contact Lenses

Presbyopia

Study ID

NCT07586982

Start date

Apr, 2026

Status verified date

May, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults, ≥40-year-old, CL wearers with best-corrected 20/20 distance visual acuity or better.
  • Requiring +0.75 ADD or more at standard near distance of 40 cm.
  • Participants will be required to have worn reusable silicone hydrogel toric CLs in the past year and still at a minimum wearing the CLs occasionally without having significant discomfort or dryness.
  • All participants will be required to have a CLDEQ-8 score <12.
  • Participants will be required to be able to wear Total 30MFT CLs (presbyopic plus astigmatism both ≥0.75D OD and 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 each day with no overnight wear.
  • Willing to wear study CLs for ≥16 hours on the Day 1 (1st full day), Day 14, and Day 29 when responses will be collected via text message.
  • Participants will be willing to wear the CL every day of the week.
  • Participants will be required to provide a glasses prescription that is less than 3 years old.
  • Visual acuity with habitual reusable silicone hydrogel toric CLs is 20/25 or better in each eye.

Exclusion Criteria:

  • Have worn Total30 MFT in the past
  • Are past rigid CL wearers
  • Are currently wearing monovision CLs
  • 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TOTAL30 Multifocal Toric contact lenses

This will be a prospective study to understand if reusable silicone hydrogel toric CL wearers who are presbyopic can be successfully refit into Total30 MFT CLs

Interventions

Total 30 multi foric contact lenses

Participants will be refit into total 30 contact lenses

Primary outcome measure

  • Visual acuity scores [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Locations

The Southern College of Optometry

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

More Information

Sponsor

Southern College of Optometry

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Optometry
  • Contact lens comfort

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southern College of Optometry on 2026-05-14.