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L'essai clinique NCT06966349 (GAMBIA) pour Caractéristiques du Film Lacrymal est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Quantifying Ocular Surface Aberrations After Tear Film Interventions (GAMBIA)

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06966349 (GAMBIA) est conçu pour étudier l'autre de Caractéristiques du Film Lacrymal. Il s'agit d'un essai interventionnel en Phase IV. Son statut actuel est : en recrutement. L'essai a débuté le 10 juin 2025 et vise à recruter 12 participants. Dirigé par University of Waterloo, l'essai devrait être terminé d'ici le 15 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 octobre 2025.
Résumé succinct
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.
Titre officiel

Quantifying Ocular Surface Aberrations After Tear Film Interventions

Conditions
Caractéristiques du Film Lacrymal
Autres identifiants de l'essai
  • GAMBIA
  • 47100
Numéro NCT
NCT06966349
Date de début (réel)
2025-06-10
Dernière mise à jour publiée
2025-10-21
Date de fin (estimée)
2025-12-15
Inscription (estimée)
12
Type d'essai
Interventionnel
PHASE
Phase IV
Statut
En recrutement
Objectif principal
Autre
Plan d'attribution
Randomisé
Modèle d'intervention
Croisé
Masquage
Double aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalExperimental: 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.
ExpérimentalExperimental: 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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
17 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  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
Contact central de l'essai
Contact: Jill Woods, MSc, MCOptom, 519-888-4567, [email protected]
Contact: Lyndon Jones, PhD, DSc, FCOptom, 519-888-4567, [email protected]
1 Centres de l'essai dans 1 pays

Ontario

Centre for Ocular Research & Education, Waterloo, Ontario, N2L 3G1, Canada
Jill Woods, MSc, MCOptom, Contact, 519-888-4567, [email protected]
Lyndon Jones, PhD, DSc, FCOptom, Investigateur principal
En recrutement