Air Optix® Night and Day® Aqua Therapeutic Wear

Completed

• Conditions: Corneal Erosion; Corneal Edema; Corneal Dystrophy; Bullous Keratopathy; Entropion
• Interventions: Device: Lotrafilcon A contact lenses; Device: Balafilcon A contact lenses

• Registration Number: NCT05956535
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.

Detailed Description

In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.

Study Timeline

• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-21
• Study Start: 2023-09-26
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
• Baseline and Follow-up (up to 1 year from Baseline) charts available.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AONDA contact lenses	Lotrafilcon A contact lenses	Lotrafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.
PV2 contact lenses	Balafilcon A contact lenses	Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.

Primary Outcome Measures

Name	Time	Method
Change from baseline in corneal pain at the Follow-up Visit - Primary exposure	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 therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the 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. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009.

Trial Locations

Locations (3)

Koetting Associates; 🇺🇸 Saint Louis, Missouri, United States

Delray Physician Care Center; 🇺🇸 Delray Beach, Florida, United States

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States