Air Optix® Night and Day® Aqua Therapeutic Wear

Corneal Edema Clinical Trial

Official title:

Air Optix® Night and Day® Aqua Therapeutic Wear

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05956535
• Other study ID #: CLD265-N001
• Status: Enrolling by invitation
• Start date: September 26, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 231
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bullous Keratopathy
• Corneal Dystrophies, Hereditary
• Corneal Dystrophy
• Corneal Edema
• Corneal Erosion
• Entropion

Intervention

Device:
• Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
• Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Contact Alcon Call Center For Trial Locations	Fort Worth	Texas
United States	Koetting Associates	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)