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Lo studio clinico NCT06966349 (GAMBIA) per Caratteristiche del Film Lacrimale è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Quantificazione delle aberrazioni della superficie oculare dopo interventi sul film lacrimale (GAMBIA)

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06966349 (GAMBIA) è uno studio interventistico di Fase IV volto a esaminare altro per Caratteristiche del Film Lacrimale, attualmente in arruolamento. Avviato il 10 giugno 2025, prevede di arruolare 12 partecipanti. Sotto la guida di University of Waterloo, dovrebbe concludersi entro il 15 dicembre 2025. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 21 ottobre 2025.
Sommario breve
The CA-800 Corneal Analyzer (Visia Imaging S.R.L., Italy) is a device that can measure small imperfections in the tear film when the eyes are open. The goal of this study is to see if the device can detect changes in the tear film after instillation of an eye drop or when contact lenses are worn.
Titolo ufficiale

Quantifying Ocular Surface Aberrations After Tear Film Interventions

Condizioni
Caratteristiche del Film Lacrimale
Altri ID dello studio
  • GAMBIA
  • 47100
Numero NCT
NCT06966349
Data di inizio (effettiva)
2025-06-10
Ultimo aggiornamento pubblicato
2025-10-21
Data di completamento (stimata)
2025-12-15
Arruolamento (previsto)
12
Tipo di studio
Interventistico
FASE
Fase IV
Stato
In arruolamento
Scopo principale
Altro
Allocazione
Randomizzato
Modello di intervento
Cross-over
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleExperimental: Systane Complete / Senofilcon A/ Somofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, senofilcon A will be worn in both eyes. On the third day of the study, somofilcon A will be worn in both eyes.
Systane Complete Preservative-free
One drop of Systane Complete Preservative Free will be instilled in each eye. Higher order aberrations assessed before and after instillation.
Senofilcon a
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.
Somofilcon a
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.
SperimentaleExperimental: Systane Complete/ Somofilcon A/ Senofilcon A
On the first day of the study, one drop of Systane Complete will be instilled in each eye. On the second day of the study, somofilcon A will be worn in both eyes. On the third day of the study, senofilcon A will be worn in both eyes.
Systane Complete Preservative-free
One drop of Systane Complete Preservative Free will be instilled in each eye. Higher order aberrations assessed before and after instillation.
Senofilcon a
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.
Somofilcon a
Daily disposable silicone hydrogel contact lenses indicated for myopia or hyperopia. Higher order aberrations assessed before and after instillation.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Change in higher order aberrations with an eye drop
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Baseline (prior to instillation); immediately, 10, 20, 30, and 60 minutes post instillation of an eye drop
Change in higher order aberrations with senofilcon A
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
Change in higher order aberrations with somofilcon A
The change in root mean square (measured in microns) was assessed over 20 seconds. Data from the right eye was analyzed.
Baseline (prior to insertion); immediately, 30 minutes, and 6 hours post insertion of a contact lens
Criteri di eleggibilità

Età idonea
Bambino, Adulto, Adulto anziano
Età minima
17 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
  1. Are at least 17 years of age and have full legal capacity to volunteer.
  2. Have signed the information consent letter.
  3. Are willing and able to follow instructions and maintain the appointment schedule.
  4. Habitually wear spherical soft contact lenses (no multifocal lens, no toric lens wear or extended (overnight) wear).
  5. Have a vertex-corrected refractive astigmatism of no more than 0.75D in each eye.
  6. Achieve a best corrected visual acuity of 0.00 logMAR or better in each eye.
  7. Agree to wear the study contact lenses for at least 6 hours.
  8. Have clear corneas (e.g. no central scars).
  9. Have no active ocular disease or inflammation.

  1. Are participating in another concurrent clinical research study.
  2. Have worn any rigid contact lenses in the past 30 days.
  3. Have been diagnosed with irregular cornea (e.g., keratoconus, etc.).
  4. Have any known active ocular condition, disease, and/or infection.*
  5. Have a systemic or ocular condition that, in the opinion of the investigator, may affect a study outcome variable.
  6. Have a known sensitivity to the diagnostic sodium fluorescein to be used in the study.
  7. Have undergone refractive error surgery.
  8. Are a member of the study team for this study, i.e. are listed on the delegation log for this study.
University of Waterloo logoUniversity of Waterloo
Contatti principali dello studio
Contatto: Jill Woods, MSc, MCOptom, 519-888-4567, [email protected]
Contatto: Lyndon Jones, PhD, DSc, FCOptom, 519-888-4567, [email protected]
1 Centri dello studio in 1 paesi

Ontario

Centre for Ocular Research & Education, Waterloo, Ontario, N2L 3G1, Canada
Jill Woods, MSc, MCOptom, Contatto, 519-888-4567, [email protected]
Lyndon Jones, PhD, DSc, FCOptom, Investigatore principale
In arruolamento