Daily Wear Corneal Infiltrative Event Study (DWCIE)
Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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-
Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Department of Ophthalmology University Hospitals Case Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- The patient must be at least 15 years old.
- The patient must be free of any anterior segment disorders.
- The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
- The patient must be correctable to 20/25 or better with spectacles.
- Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
- Can be successfully fit with lotrafilcon A lenses at the enrollment visit.
Exclusion Criteria
- The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
- The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
- The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
- The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
- The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
- The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
- The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.
- The patient is pregnant.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Comparatore attivo: ReNu Multiplus and lotrafilcon A lenses
ReNu Multiplus contact lens care solution
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FDA approved soft contact lenses
Altri nomi:
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Comparatore attivo: Clear Care solution and lotrafilcon A lenses
Clear Care Contact Lens Care Solution
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FDA approved soft contact lenses
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants Developing a Corneal Inflammatory Event (CIE)
Lasso di tempo: up to 1 year
|
Raw number of participants in each solution arm developing CIE over 12 month follow-up period
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up to 1 year
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
Lasso di tempo: up to 1 year
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Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses
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up to 1 year
|
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Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
Lasso di tempo: up to 1 year
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Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones
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up to 1 year
|
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Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
Lasso di tempo: up to 1 year
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Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora
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up to 1 year
|
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Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
Lasso di tempo: up to 1 year
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Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids
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up to 1 year
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Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
Lasso di tempo: up to 1 year
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Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids
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up to 1 year
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Loretta Szczotka-Flynn, OD, PhD, University Hospitals Cleveland Medical Center
Pubblicazioni e link utili
Pubblicazioni generali
- Szczotka-Flynn L, Jiang Y, Raghupathy S, Bielefeld RA, Garvey MT, Jacobs MR, Kern J, Debanne SM. Corneal inflammatory events with daily silicone hydrogel lens wear. Optom Vis Sci. 2014 Jan;91(1):3-12. doi: 10.1097/OPX.0000000000000105.
- Jiang Y, Jacobs M, Bajaksouzian S, Foster AN, Debanne SM, Bielefeld R, Garvey M, Raghupathy S, Kern J, Szczotka-Flynn LB. Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses. Eye Contact Lens. 2014 May;40(3):148-56. doi: 10.1097/ICL.0000000000000026.
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 001 (Marta Eliza Miller Foundation)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .