- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07586982
Clinical Performance of Verofilcon A Toric Contact Lenses
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Chris Lievens, OD
- Telefonnummer: (901) 722-3200
- E-Mail: clievens@sco.edu
Studienorte
-
-
Tennessee
-
Memphis, Tennessee, Vereinigte Staaten, 38104
- Rekrutierung
- The Southern College of Optometry
-
Kontakt:
- Chris Lievens, OD
- Telefonnummer: 9014815699
- E-Mail: clievens@sco.edu
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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
|
Participants will be refit into total 30 contact lenses
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Visual acuity scores
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Contact lens dry eye 8 questionnaire scores
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00006763-Total30MFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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