AONDA Therapeutic Indication Study I

Sponsor

Alcon Research (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891106

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

50.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be used to support assessment of AIR OPTIX® NIGHT & DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.

Condition or Disease	Intervention/Treatment	Phase
Bullous Keratopathy Corneal Erosion Entropion Corneal Edema Corneal Dystrophy Corneal Ulcer Foreign Body in Cornea Bell Palsy Keratoconjunctivitis Filamentary Keratitis Sicca Syndrome; Keratoconjunctivitis (Etiology)	Device: Lotrafilcon A contact lenses

Detailed Description

In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

AONDA Therapeutic Indication Study I

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
AONDA Therapeutic Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional	Device: Lotrafilcon A contact lenses CE-marked silicone hydrogel contact lenses Other Names: AONDA AIR OPTIX® NIGHT & DAY® AQUA

Arm

Intervention/Treatment

AONDA Therapeutic

Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional

Device: Lotrafilcon A contact lenses

CE-marked silicone hydrogel contact lenses

Other Names:

AONDA

AIR OPTIX® NIGHT & DAY® AQUA

Outcome Measures

Primary Outcome Measures

Change from baseline in corneal pain at the Follow-up Visit [Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)]
The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) at Baseline.
Baseline and Follow-up (up to 1 year from Baseline) charts available.
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.
Other protocol-defined exclusion criteria may apply.