Air Optix® Night and Day® Aqua Therapeutic Wear

NCT05956535 | Completed FDA Device

• 1 other identifier: CLD265-N001
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 3

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.

Conditions

Bullous Keratopathy; Corneal Erosion; Entropion; Corneal Edema; Corneal Dystrophy

Keywords

Bandage lens

Outcome Measures

Primary Outcomes (1)

• Change from baseline in corneal pain at the Follow-up Visit - Primary exposure

  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.

  Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)

Study Arms (2)

AONDA 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.

Device: Lotrafilcon A contact lenses

PV2 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.

Device: Balafilcon A contact lenses

Interventions

Lotrafilcon A contact lenses DEVICE

CE-marked silicone hydrogel contact lenses

Also known as: Air Optix® Night and Day® Aqua, AONDA

AONDA contact lenses

Balafilcon A contact lenses DEVICE

CE-marked silicone hydrogel contact lenses

Also known as: PureVision® 2, PV2

PV2 contact lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (3)

Delray Physician Care Center

Delray Beach, Florida, 33445, United States

Location

Koetting Associates

St Louis, Missouri, 63144, United States

Location

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Entropion; Corneal Edema; Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Corneal Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Trial Lead, CRD Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: September 26, 2023
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)