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Clinical Performance of Verofilcon A Toric Contact Lenses

7. maj 2026 opdateret af: Southern College of Optometry

Clinical Performance of Verofilcon A Toric Contact Lenses in Satisfied Wearers of Senofilcon A Toric Contact Lenses With Blue Light Filtration

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Enhed: Total 30 multi foric contact lenses

Detaljeret beskrivelse

TOTAL30® Multifocal Toric contact lenses (CLs) are a 1-month, silicone hydrogel (lehfilcon A), studies have likewise found the lehfilcon A material to provides a comfortable wearing experience for the full life of the CL and for the full CL wear day.1 While initial TOTAL30 data are promising, the literature currently lacks data directly related to the Total30 MFT design and a targeted study aimed at evaluating how Total30 MFT performs with regards to overall comfort, vision, and satisfaction for those who are previous reusable toric CL wearers and are now presbyopic. This transition could be particularly important for patients who are presbyopic and astigmatic given that these two patients groups tend to struggle more with CLs than spherical CL wearers. Thus, the purpose of this work is to determine Total30 MFT overall comfort, vision, willingness to remain in CLs after the study, and satisfaction for those who currently wear reusable silicone hydrogel toric CLs and are now presbyopic. These data will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting presbyopic patients who have astigmatism into Total30 MFT, especially after the onset of presbyopia.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Chris Lievens, OD
Telefonnummer: (901) 722-3200
E-mail: clievens@sco.edu

Studiesteder

Forenede Stater
- Tennessee
  - Memphis, Tennessee, Forenede Stater, 38104
    - Rekruttering
    - The Southern College of Optometry
    - Kontakt:
      
      Chris Lievens, OD
      
      Telefonnummer: 9014815699
      
      E-mail: clievens@sco.edu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen

Tager imod sunde frivillige

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 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	Enhed: Total 30 multi foric contact lenses Participants will be refit into total 30 contact lenses

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Visual acuity scores Tidsramme: 1 month	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 VAS scores will be judged from -50 to positive 50 with positive numbers being more comfortable and 0 being neutral.	1 month

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Contact lens dry eye 8 questionnaire scores Tidsramme: 1 month	Proportion of reusable silicone hydrogel toric CL wearers who have asymptomatic Contact Lens Dry Eye-8 (CLDEQ-8; scores <12) scores one month after wearing Total30 MFT CL	1 month
Comfort VAS Tidsramme: Day 1, Day 14 and day 29 text messages	Comfort VAS after application and at 8, 12, and 16 hours of wear on Day 1 (1st full day), Day14, and Day 29 via text.	Day 1, Day 14 and day 29 text messages

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southern College of Optometry

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

IRB00006763-Total30MFT

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.

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Clinical Performance of Verofilcon A Toric Contact Lenses